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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 12:16 AM

Ignite Modification Date: 2026-02-23 @ 1:53 PM

Study NCT ID: NCT00422058

Status: COMPLETED

Last Update Posted: 2017-11-01

First Post: 2007-01-12

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'D000077403', 'term': 'Orlistat'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': "Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk's Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The adverse events were collected over 104 weeks.', 'description': 'Safety analysis set consists of all subjects exposed to trial product(s).', 'eventGroups': [{'id': 'EG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)', 'otherNumAtRisk': 98, 'otherNumAffected': 90, 'seriousNumAtRisk': 98, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)', 'otherNumAtRisk': 95, 'otherNumAffected': 90, 'seriousNumAtRisk': 95, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)', 'otherNumAtRisk': 90, 'otherNumAffected': 86, 'seriousNumAtRisk': 90, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)', 'otherNumAtRisk': 93, 'otherNumAffected': 89, 'seriousNumAtRisk': 93, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)', 'otherNumAtRisk': 93, 'otherNumAffected': 90, 'seriousNumAtRisk': 93, 'seriousNumAffected': 10}, {'id': 'EG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)', 'otherNumAtRisk': 95, 'otherNumAffected': 89, 'seriousNumAtRisk': 95, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 29, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 23, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 49, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 40, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 47, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 40, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 61, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 76, 'numAffected': 47}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Steatorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 24, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 31, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 37, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 23, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 39, 'numAffected': 22}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 39, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 85, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 69, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 71, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 80, 'numAffected': 42}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 74, 'numAffected': 38}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 46, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 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'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Thyroglossal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 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'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Transient 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{'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 10.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 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Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '97.3', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '96.4', 'spread': '13.4', 'groupId': 'OG001'}, {'value': '98.0', 'spread': '12.5', 'groupId': 'OG002'}, {'value': '98.4', 'spread': '13.1', 'groupId': 'OG003'}, {'value': '97.5', 'spread': '13.8', 'groupId': 'OG004'}, {'value': '96.0', 'spread': '11.7', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 20', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '-5.9', 'spread': '5.0', 'groupId': 'OG002'}, {'value': '-6.6', 'spread': '4.6', 'groupId': 'OG003'}, {'value': '-7.6', 'spread': '4.6', 'groupId': 'OG004'}, {'value': '-4.4', 'spread': '4.1', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean body weight at week 20 - baseline', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Body Weight at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '97.3', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '96.4', 'spread': '13.4', 'groupId': 'OG001'}, {'value': '98.0', 'spread': '12.5', 'groupId': 'OG002'}, {'value': '98.4', 'spread': '13.1', 'groupId': 'OG003'}, {'value': '97.5', 'spread': '13.8', 'groupId': 'OG004'}, {'value': '96.0', 'spread': '11.7', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 104', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '-5.6', 'spread': '6.5', 'groupId': 'OG002'}, {'value': '-6.4', 'spread': '7.2', 'groupId': 'OG003'}, {'value': '-8.2', 'spread': '7.1', 'groupId': 'OG004'}, {'value': '-3.8', 'spread': '6.4', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean body weight at week 104 - baseline', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}, {'value': '89', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.42', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '5.30', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '5.29', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '5.27', 'spread': '0.57', 'groupId': 'OG003'}, {'value': '5.36', 'spread': '0.61', 'groupId': 'OG004'}, {'value': '5.3', 'spread': '0.51', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 20', 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '-0.44', 'spread': '0.63', 'groupId': 'OG002'}, {'value': '-0.38', 'spread': '0.48', 'groupId': 'OG003'}, {'value': '-0.44', 'spread': '0.44', 'groupId': 'OG004'}, {'value': '-0.10', 'spread': '0.41', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean fasting plasma glucose at week 20 - baseline', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}, {'value': '89', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.42', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '5.30', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '5.29', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '5.27', 'spread': '0.57', 'groupId': 'OG003'}, {'value': '5.36', 'spread': '0.61', 'groupId': 'OG004'}, {'value': '5.30', 'spread': '0.51', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 104', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '-0.20', 'spread': '0.50', 'groupId': 'OG003'}, {'value': '-0.23', 'spread': '0.50', 'groupId': 'OG004'}, {'value': '0.02', 'spread': '0.48', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean fasting plasma glucose at week 104 - baseline', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Insulin at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '99.5', 'spread': '129.2', 'groupId': 'OG000'}, {'value': '82.9', 'spread': '43.0', 'groupId': 'OG001'}, {'value': '85.7', 'spread': '49.5', 'groupId': 'OG002'}, {'value': '88.7', 'spread': '43.3', 'groupId': 'OG003'}, {'value': '89.1', 'spread': '51.9', 'groupId': 'OG004'}, {'value': '85.5', 'spread': '48.3', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 20', 'categories': [{'measurements': [{'value': '-15.0', 'spread': '34.0', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '105.3', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '48.2', 'groupId': 'OG002'}, {'value': '-3.9', 'spread': '53.2', 'groupId': 'OG003'}, {'value': '-12.3', 'spread': '43.3', 'groupId': 'OG004'}, {'value': '-16.7', 'spread': '60.6', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean fasting insulin at week 20 - baseline', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Insulin at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '99.5', 'spread': '129.2', 'groupId': 'OG000'}, {'value': '82.9', 'spread': '43.0', 'groupId': 'OG001'}, {'value': '85.7', 'spread': '49.5', 'groupId': 'OG002'}, {'value': '88.7', 'spread': '43.3', 'groupId': 'OG003'}, {'value': '89.1', 'spread': '51.9', 'groupId': 'OG004'}, {'value': '85.5', 'spread': '48.3', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 104', 'categories': [{'measurements': [{'value': '0.7', 'spread': '53.6', 'groupId': 'OG000'}, {'value': '-13.5', 'spread': '39.7', 'groupId': 'OG001'}, {'value': '18.6', 'spread': '102.6', 'groupId': 'OG002'}, {'value': '-2.1', 'spread': '47.3', 'groupId': 'OG003'}, {'value': '-19.6', 'spread': '44.3', 'groupId': 'OG004'}, {'value': '-15.3', 'spread': '39.8', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean fasting insulin at week 104 - baseline', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.60', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '5.58', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '5.60', 'spread': '0.40', 'groupId': 'OG002'}, {'value': '5.54', 'spread': '0.34', 'groupId': 'OG003'}, {'value': '5.57', 'spread': '0.40', 'groupId': 'OG004'}, {'value': '5.55', 'spread': '0.32', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 20', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '-0.21', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '-0.22', 'spread': '0.25', 'groupId': 'OG003'}, {'value': '-0.24', 'spread': '0.29', 'groupId': 'OG004'}, {'value': '0.00', 'spread': '0.21', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline', 'unitOfMeasure': 'percentage (%) of total haemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.60', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '5.58', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '5.60', 'spread': '0.40', 'groupId': 'OG002'}, {'value': '5.54', 'spread': '0.34', 'groupId': 'OG003'}, {'value': '5.57', 'spread': '0.40', 'groupId': 'OG004'}, {'value': '5.55', 'spread': '0.32', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 104', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '-0.30', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '-0.25', 'spread': '0.30', 'groupId': 'OG003'}, {'value': '-0.35', 'spread': '0.32', 'groupId': 'OG004'}, {'value': '-0.18', 'spread': '0.37', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline', 'unitOfMeasure': 'percentage (%) of total haemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.6', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '4.5', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '4.2', 'groupId': 'OG003'}, {'value': '3.8', 'spread': '7.4', 'groupId': 'OG004'}, {'value': '4.6', 'spread': '4.5', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 20', 'categories': [{'measurements': [{'value': '0.8', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '2.9', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '4.7', 'groupId': 'OG003'}, {'value': '-1.1', 'spread': '7.2', 'groupId': 'OG004'}, {'value': '-0.3', 'spread': '4.2', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.6', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '4.5', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '4.2', 'groupId': 'OG003'}, {'value': '3.8', 'spread': '7.4', 'groupId': 'OG004'}, {'value': '4.6', 'spread': '4.5', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 104', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '6.0', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '8.6', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '3.2', 'groupId': 'OG003'}, {'value': '-2.1', 'spread': '9.3', 'groupId': 'OG004'}, {'value': '2.4', 'spread': '19.4', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '65', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '21.6', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '19.7', 'spread': '9.8', 'groupId': 'OG002'}, {'value': '17.6', 'spread': '8.7', 'groupId': 'OG003'}, {'value': '19.0', 'spread': '9.1', 'groupId': 'OG004'}, {'value': '17.4', 'spread': '8.2', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 20', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '9.5', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '9.5', 'groupId': 'OG003'}, {'value': '-4.5', 'spread': '8.5', 'groupId': 'OG004'}, {'value': '-1.2', 'spread': '8.8', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk', 'unitOfMeasure': 'U/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '21.6', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '19.7', 'spread': '9.8', 'groupId': 'OG002'}, {'value': '17.6', 'spread': '8.7', 'groupId': 'OG003'}, {'value': '19.0', 'spread': '9.1', 'groupId': 'OG004'}, {'value': '17.4', 'spread': '8.2', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 104', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '9.1', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '9.8', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '9.9', 'groupId': 'OG003'}, {'value': '0.4', 'spread': '10.9', 'groupId': 'OG004'}, {'value': '2.9', 'spread': '7.4', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 104-baseline. High PAI-1 is associated with greater cardiovascular risk', 'unitOfMeasure': 'U/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fibrinogen at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}, {'value': '67', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.60', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '3.67', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '3.75', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '3.64', 'spread': '0.72', 'groupId': 'OG003'}, {'value': '3.61', 'spread': '0.68', 'groupId': 'OG004'}, {'value': '3.68', 'spread': '0.82', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 20', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '0.10', 'spread': '0.69', 'groupId': 'OG003'}, {'value': '0.05', 'spread': '0.55', 'groupId': 'OG004'}, {'value': '-0.12', 'spread': '0.75', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fibrinogen at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.60', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '3.67', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '3.75', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '3.64', 'spread': '0.72', 'groupId': 'OG003'}, {'value': '3.61', 'spread': '0.68', 'groupId': 'OG004'}, {'value': '3.68', 'spread': '0.82', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 104', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '-0.15', 'spread': '0.98', 'groupId': 'OG002'}, {'value': '-0.24', 'spread': '0.74', 'groupId': 'OG003'}, {'value': '-0.22', 'spread': '0.82', 'groupId': 'OG004'}, {'value': '-0.39', 'spread': '1.24', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Adiponectin at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}, {'value': '77', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.1', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '4.6', 'groupId': 'OG002'}, {'value': '6.2', 'spread': '4.6', 'groupId': 'OG003'}, {'value': '6.1', 'spread': '4.0', 'groupId': 'OG004'}, {'value': '5.4', 'spread': '4.7', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 20', 'categories': [{'measurements': [{'value': '2.3', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '6.9', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '5.7', 'groupId': 'OG003'}, {'value': '2.3', 'spread': '4.6', 'groupId': 'OG004'}, {'value': '1.7', 'spread': '4.4', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean adiponectin at week 20-baseline. A low adiponectin level is associated with greater cardiovascular risk', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Adiponectin at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.1', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '4.6', 'groupId': 'OG002'}, {'value': '6.2', 'spread': '4.6', 'groupId': 'OG003'}, {'value': '6.1', 'spread': '4.0', 'groupId': 'OG004'}, {'value': '5.4', 'spread': '4.7', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 104', 'categories': [{'measurements': [{'value': '3.5', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '3.9', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '5.4', 'groupId': 'OG003'}, {'value': '3.2', 'spread': '4.1', 'groupId': 'OG004'}, {'value': '3.1', 'spread': '4.2', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Waist Circumference at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}, {'value': '87', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '108.3', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '109.0', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '108.2', 'spread': '9.5', 'groupId': 'OG002'}, {'value': '110.4', 'spread': '10.6', 'groupId': 'OG003'}, {'value': '108.7', 'spread': '8.3', 'groupId': 'OG004'}, {'value': '107.6', 'spread': '9.7', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 20', 'categories': [{'measurements': [{'value': '-4.2', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '-5.9', 'spread': '5.3', 'groupId': 'OG002'}, {'value': '-7.2', 'spread': '5.8', 'groupId': 'OG003'}, {'value': '-7.9', 'spread': '5.5', 'groupId': 'OG004'}, {'value': '-6.0', 'spread': '5.4', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean waist circumference at week 20-baseline.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Waist Circumference at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '108.3', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '109.0', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '108.2', 'spread': '9.5', 'groupId': 'OG002'}, {'value': '110.4', 'spread': '10.6', 'groupId': 'OG003'}, {'value': '108.7', 'spread': '8.3', 'groupId': 'OG004'}, {'value': '107.6', 'spread': '9.7', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 104', 'categories': [{'measurements': [{'value': '-10.0', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '-8.6', 'spread': '7.5', 'groupId': 'OG001'}, {'value': '-9.0', 'spread': '8.7', 'groupId': 'OG002'}, {'value': '-10.4', 'spread': '7.8', 'groupId': 'OG003'}, {'value': '-9.8', 'spread': '7.5', 'groupId': 'OG004'}, {'value': '-9.5', 'spread': '7.3', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean waist circumference at week 104-baseline.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Pressure at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}, {'value': '90', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline (Systolic )', 'categories': [{'measurements': [{'value': '123.6', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '127.2', 'spread': '13.1', 'groupId': 'OG001'}, {'value': '123.4', 'spread': '13.0', 'groupId': 'OG002'}, {'value': '126.3', 'spread': '13.9', 'groupId': 'OG003'}, {'value': '124.3', 'spread': '11.3', 'groupId': 'OG004'}, {'value': '122.7', 'spread': '13.5', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 20 (Systolic)', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '-4.8', 'spread': '12.7', 'groupId': 'OG002'}, {'value': '-9.1', 'spread': '12.3', 'groupId': 'OG003'}, {'value': '-6.4', 'spread': '10.0', 'groupId': 'OG004'}, {'value': '-4.3', 'spread': '10.9', 'groupId': 'OG005'}]}]}, {'title': 'Baseline (Diastolic)', 'categories': [{'measurements': [{'value': '76.78', 'spread': '8.50', 'groupId': 'OG000'}, {'value': '79.71', 'spread': '9.12', 'groupId': 'OG001'}, {'value': '77.91', 'spread': '7.92', 'groupId': 'OG002'}, {'value': '78.53', 'spread': '8.23', 'groupId': 'OG003'}, {'value': '77.84', 'spread': '8.38', 'groupId': 'OG004'}, {'value': '76.94', 'spread': '7.94', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 20 (Diastolic)', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '7.52', 'groupId': 'OG000'}, {'value': '-1.53', 'spread': '9.15', 'groupId': 'OG001'}, {'value': '-1.61', 'spread': '8.04', 'groupId': 'OG002'}, {'value': '-1.39', 'spread': '7.79', 'groupId': 'OG003'}, {'value': '-2.37', 'spread': '7.71', 'groupId': 'OG004'}, {'value': '-1.96', 'spread': '7.82', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean blood pressure at week 20-baseline.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Pressure at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}, {'value': '90', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'OG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'classes': [{'title': 'Baseline (Systolic )', 'categories': [{'measurements': [{'value': '123.6', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '127.2', 'spread': '13.1', 'groupId': 'OG001'}, {'value': '123.4', 'spread': '13.0', 'groupId': 'OG002'}, {'value': '126.3', 'spread': '13.9', 'groupId': 'OG003'}, {'value': '124.3', 'spread': '11.3', 'groupId': 'OG004'}, {'value': '122.7', 'spread': '13.5', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 104 (Systolic)', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '13.4', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '16.0', 'groupId': 'OG002'}, {'value': '-6.5', 'spread': '12.6', 'groupId': 'OG003'}, {'value': '-5.6', 'spread': '11.7', 'groupId': 'OG004'}, {'value': '-2.0', 'spread': '11.7', 'groupId': 'OG005'}]}]}, {'title': 'Baseline (Diastolic)', 'categories': [{'measurements': [{'value': '76.78', 'spread': '8.50', 'groupId': 'OG000'}, {'value': '79.71', 'spread': '9.12', 'groupId': 'OG001'}, {'value': '77.91', 'spread': '7.92', 'groupId': 'OG002'}, {'value': '78.53', 'spread': '8.23', 'groupId': 'OG003'}, {'value': '77.84', 'spread': '8.38', 'groupId': 'OG004'}, {'value': '76.94', 'spread': '7.94', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 104 (Diastolic)', 'categories': [{'measurements': [{'value': '1.64', 'spread': '8.47', 'groupId': 'OG000'}, {'value': '-0.98', 'spread': '9.81', 'groupId': 'OG001'}, {'value': '-1.00', 'spread': '9.37', 'groupId': 'OG002'}, {'value': '-1.99', 'spread': '9.61', 'groupId': 'OG003'}, {'value': '-1.92', 'spread': '9.41', 'groupId': 'OG004'}, {'value': '-1.11', 'spread': '8.36', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean blood pressure at week 104-baseline.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'FG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'FG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'FG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'FG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'FG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}], 'periods': [{'title': 'Double-Blind, Week 0-20', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '95'}, {'groupId': 'FG002', 'numSubjects': '90'}, {'groupId': 'FG003', 'numSubjects': '93'}, {'groupId': 'FG004', 'numSubjects': '93'}, {'groupId': 'FG005', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '74'}, {'groupId': 'FG003', 'numSubjects': '73'}, {'groupId': 'FG004', 'numSubjects': '82'}, {'groupId': 'FG005', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '10'}]}]}, {'title': 'Open-Label Extension, Week 20-104', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '74'}, {'groupId': 'FG003', 'numSubjects': '73'}, {'groupId': 'FG004', 'numSubjects': '82'}, {'groupId': 'FG005', 'numSubjects': '79'}]}, {'type': 'Enrolled in Extension', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '68'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '65'}, {'groupId': 'FG004', 'numSubjects': '72'}, {'groupId': 'FG005', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '45'}, {'groupId': 'FG004', 'numSubjects': '47'}, {'groupId': 'FG005', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '35'}, {'groupId': 'FG005', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Not giving consent for extension', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '18'}]}]}], 'recruitmentDetails': '19 sites in 8 countries: Denmark (3), Sweden (2), Finland (3), UK (3), Netherlands (1), Belgium (1), Spain (4) and Czech Republic (2)', 'preAssignmentDetails': 'Between screening and randomisation, eligible subjects were included in a 2-week single-blind run-in period in which all subjects were placed on a hypocaloric diet. The dose of liraglutide and placebo was increased during the first 4 weeks after randomisation until maintenance dose was reached. Orlistat dose was fixed from randomisation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}, {'value': '95', 'groupId': 'BG005'}, {'value': '564', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Lira Placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'BG001', 'title': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'BG002', 'title': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'BG003', 'title': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'BG004', 'title': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)'}, {'id': 'BG005', 'title': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.86', 'spread': '10.28', 'groupId': 'BG000'}, {'value': '47.18', 'spread': '9.72', 'groupId': 'BG001'}, {'value': '45.53', 'spread': '10.9', 'groupId': 'BG002'}, {'value': '45.01', 'spread': '11.09', 'groupId': 'BG003'}, {'value': '45.91', 'spread': '10.71', 'groupId': 'BG004'}, {'value': '45.94', 'spread': '9.11', 'groupId': 'BG005'}, {'value': '45.91', 'spread': '10.29', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}, {'value': '73', 'groupId': 'BG005'}, {'value': '429', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '135', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}, {'value': '93', 'groupId': 'BG005'}, {'value': '555', 'groupId': 'BG006'}]}]}, {'title': 'American Indian/Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '34.8', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '35.0', 'spread': '2.6', 'groupId': 'BG002'}, {'value': '35.0', 'spread': '2.8', 'groupId': 'BG003'}, {'value': '34.8', 'spread': '2.8', 'groupId': 'BG004'}, {'value': '34.1', 'spread': '2.6', 'groupId': 'BG005'}, {'value': '34.8', 'spread': '2.7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'BMI = Body Mass Index', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '97.3', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '96.2', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '98.0', 'spread': '12.5', 'groupId': 'BG002'}, {'value': '98.4', 'spread': '13.0', 'groupId': 'BG003'}, {'value': '97.6', 'spread': '13.7', 'groupId': 'BG004'}, {'value': '96.0', 'spread': '11.7', 'groupId': 'BG005'}, {'value': '97.2', 'spread': '12.8', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '108.3', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '108.8', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '108.2', 'spread': '9.5', 'groupId': 'BG002'}, {'value': '110.2', 'spread': '10.7', 'groupId': 'BG003'}, {'value': '108.9', 'spread': '8.3', 'groupId': 'BG004'}, {'value': '107.6', 'spread': '9.7', 'groupId': 'BG005'}, {'value': '108.7', 'spread': '9.8', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '5.60', 'spread': '0.38', 'groupId': 'BG000'}, {'value': '5.58', 'spread': '0.33', 'groupId': 'BG001'}, {'value': '5.60', 'spread': '0.40', 'groupId': 'BG002'}, {'value': '5.54', 'spread': '0.33', 'groupId': 'BG003'}, {'value': '5.57', 'spread': '0.40', 'groupId': 'BG004'}, {'value': '5.55', 'spread': '0.32', 'groupId': 'BG005'}, {'value': '5.60', 'spread': '0.4', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'HbA1c = glycosylated haemoglobin A1c', 'unitOfMeasure': 'percentage (%) of total haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood pressure', 'classes': [{'title': 'Systolic', 'categories': [{'measurements': [{'value': '123.6', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '127.0', 'spread': '13.1', 'groupId': 'BG001'}, {'value': '123.4', 'spread': '13.0', 'groupId': 'BG002'}, {'value': '126.2', 'spread': '13.9', 'groupId': 'BG003'}, {'value': '124.3', 'spread': '11.3', 'groupId': 'BG004'}, {'value': '122.7', 'spread': '13.5', 'groupId': 'BG005'}, {'value': '124.5', 'spread': '12.7', 'groupId': 'BG006'}]}]}, {'title': 'Diastolic', 'categories': [{'measurements': [{'value': '76.8', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '79.7', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '77.9', 'spread': '7.9', 'groupId': 'BG002'}, {'value': '78.6', 'spread': '8.2', 'groupId': 'BG003'}, {'value': '77.8', 'spread': '8.3', 'groupId': 'BG004'}, {'value': '76.9', 'spread': '7.9', 'groupId': 'BG005'}, {'value': '77.9', 'spread': '8.4', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 564}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2009-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-29', 'studyFirstSubmitDate': '2007-01-12', 'resultsFirstSubmitDate': '2010-04-27', 'studyFirstSubmitQcDate': '2007-01-12', 'lastUpdatePostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-10-05', 'studyFirstPostDateStruct': {'date': '2007-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Body Weight at Week 20', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean body weight at week 20 - baseline'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Body Weight at Week 104', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean body weight at week 104 - baseline'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose at Week 20', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean fasting plasma glucose at week 20 - baseline'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose at Week 104', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean fasting plasma glucose at week 104 - baseline'}, {'measure': 'Change From Baseline in Fasting Insulin at Week 20', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean fasting insulin at week 20 - baseline'}, {'measure': 'Change From Baseline in Fasting Insulin at Week 104', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean fasting insulin at week 104 - baseline'}, {'measure': 'Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline'}, {'measure': 'Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline'}, {'measure': 'Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk'}, {'measure': 'Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk'}, {'measure': 'Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk'}, {'measure': 'Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 104-baseline. High PAI-1 is associated with greater cardiovascular risk'}, {'measure': 'Change From Baseline in Fibrinogen at Week 20', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk'}, {'measure': 'Change From Baseline in Fibrinogen at Week 104', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk'}, {'measure': 'Change From Baseline in Adiponectin at Week 20', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean adiponectin at week 20-baseline. A low adiponectin level is associated with greater cardiovascular risk'}, {'measure': 'Change From Baseline in Adiponectin at Week 104', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk'}, {'measure': 'Change From Baseline in Waist Circumference at Week 20', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean waist circumference at week 20-baseline.'}, {'measure': 'Change From Baseline in Waist Circumference at Week 104', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean waist circumference at week 104-baseline.'}, {'measure': 'Change From Baseline in Blood Pressure at Week 20', 'timeFrame': 'Week 0, week 20', 'description': 'Calculated as mean blood pressure at week 20-baseline.'}, {'measure': 'Change From Baseline in Blood Pressure at Week 104', 'timeFrame': 'Week 0, week 104', 'description': 'Calculated as mean blood pressure at week 104-baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolism and Nutrition Disorder', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '21844879', 'type': 'RESULT', 'citation': 'Astrup A, Carraro R, Finer N, Harper A, Kunesova M, Lean ME, Niskanen L, Rasmussen MF, Rissanen A, Rossner S, Savolainen MJ, Van Gaal L; NN8022-1807 Investigators. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes (Lond). 2012 Jun;36(6):843-54. doi: 10.1038/ijo.2011.158. Epub 2011 Aug 16.'}, {'pmid': '19853906', 'type': 'RESULT', 'citation': 'Astrup A, Rossner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23.'}, {'pmid': '23942319', 'type': 'RESULT', 'citation': 'Lean ME, Carraro R, Finer N, Hartvig H, Lindegaard ML, Rossner S, Van Gaal L, Astrup A; NN8022-1807 Investigators. Tolerability of nausea and vomiting and associations with weight loss in a randomized trial of liraglutide in obese, non-diabetic adults. Int J Obes (Lond). 2014 May;38(5):689-97. doi: 10.1038/ijo.2013.149. Epub 2013 Aug 14.'}, {'pmid': '28473337', 'type': 'RESULT', 'citation': 'Steinberg WM, Rosenstock J, Wadden TA, Donsmark M, Jensen CB, DeVries JH. Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Pooled Data From the SCALE Clinical Development Program. Diabetes Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4.'}, {'pmid': '28386912', 'type': 'RESULT', 'citation': "O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21."}, {'pmid': '28950422', 'type': 'RESULT', 'citation': 'Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide.\n\nTrial has the following trial periods: A 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) greater than or equal to 30.0 or lesser than or equal to 40.0 kg/m2\n* Stable body weight (less than 5% selfreported change within the last 3 months)\n\nExclusion Criteria:\n\n* Obesity induced by drug treatment\n* Use of approved drugs for weight lowering intervention (e.g. orlistat, sibutramin, rimonabant) within the last 3 months prior to entering trial\n* Type 1 or type 2 diabetes'}, 'identificationModule': {'nctId': 'NCT00422058', 'briefTitle': 'The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes', 'nctIdAliases': ['NCT00480909'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes: A 20-week Randomised, Double-blind, Placebo-controlled, Six Armed Parallel Group, Multi-centre, Multinational Trial With an Open Label Orlistat Comparator Arm and With an 84-week Extension Period', 'orgStudyIdInfo': {'id': 'NN8022-1807'}, 'secondaryIdInfos': [{'id': '2006-004481-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Lira placebo/Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Lira 1.2 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)', 'interventionNames': ['Drug: liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Lira 1.8 mg/Lira 3.0 mg', 'description': 'Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)', 'interventionNames': ['Drug: liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Lira 2.4 mg/Lira 3.0 mg', 'description': 'Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)', 'interventionNames': ['Drug: liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Liraglutide 3.0 mg', 'description': 'Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)', 'interventionNames': ['Drug: liraglutide', 'Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Orlistat', 'description': 'Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)', 'interventionNames': ['Drug: orlistat']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': 'Injected s.c. (under the skin) once daily', 'armGroupLabels': ['Lira 1.2 mg/Lira 3.0 mg', 'Lira 1.8 mg/Lira 3.0 mg', 'Lira 2.4 mg/Lira 3.0 mg', 'Liraglutide 3.0 mg']}, {'name': 'orlistat', 'type': 'DRUG', 'description': '120 mg capsule. Administered thrice daily', 'armGroupLabels': ['Orlistat']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Injected s.c. (under the skin) once daily', 'armGroupLabels': ['Lira placebo/Lira 2.4 mg/Lira 3.0 mg', 'Liraglutide 3.0 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '116 94', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '128 08', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '8000', 'city': 'Århus C', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '1958', 'city': 'Frederiksberg C', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '00270', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '70210', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '90220', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '1311RL', 'city': 'Almere Stad', 'country': 'Netherlands', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.37025, 'lon': 5.21413}}, {'zip': '08022', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'G322ER', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'LU4 0DZ', 'city': 'Luton', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.87967, 'lon': -0.41748}}, {'zip': 'NR4 7TJ', 'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}