Ignite Creation Date:
2025-12-24 @ 3:39 PM
Ignite Modification Date:
2026-03-14 @ 4:51 AM
Study NCT ID:
NCT03486392
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2018-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Senior Director Clinical Leader', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 Weeks', 'description': 'Safety analysis set included all randomized participants who had received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Double Blind: Placebo', 'description': 'Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 33, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Double Blind: JNJ-64565111 5.0 mg', 'description': 'Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 43, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Double Blind: JNJ-64565111 7.4 mg', 'description': 'Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 106, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Double Blind: JNJ-64565111 10.0 mg', 'description': 'Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 104, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Open Label: Liraglutide 3.0 mg', 'description': 'Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 81, 'seriousNumAtRisk': 119, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 80}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 79}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 48}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 64}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Injection Site Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Hepatic Enzyme Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}], 'seriousEvents': [{'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Stress Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Pancreatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Umbilical Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Biliary Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Major Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Body Weight at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Double Blind: Placebo', 'description': 'Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG001', 'title': 'Double Blind: JNJ-64565111 5.0 mg', 'description': 'Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG002', 'title': 'Double Blind: JNJ-64565111 7.4 mg', 'description': 'Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG003', 'title': 'Double Blind: JNJ-64565111 10.0 mg', 'description': 'Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG004', 'title': 'Open Label: Liraglutide 3.0 mg', 'description': 'Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.76', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '-8.51', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '-9.83', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '-11.80', 'spread': '0.58', 'groupId': 'OG003'}, {'value': '-7.54', 'spread': '0.54', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of least square (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.75', 'ciLowerLimit': '-9.31', 'ciUpperLimit': '-4.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.056', 'statisticalMethod': "Dunnett's method", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.07', 'ciLowerLimit': '-10.31', 'ciUpperLimit': '-5.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.921', 'statisticalMethod': "Dunnett's method", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.04', 'ciLowerLimit': '-12.31', 'ciUpperLimit': '-7.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.934', 'statisticalMethod': "Dunnett's method", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.78', 'ciLowerLimit': '-7.99', 'ciUpperLimit': '-3.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.910', 'statisticalMethod': "Dunnett's method", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population. N (number of participants analyzed) = participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '119', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Double Blind: Placebo', 'description': 'Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG001', 'title': 'Double Blind: JNJ-64565111 5.0 mg', 'description': 'Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG002', 'title': 'Double Blind: JNJ-64565111 7.4 mg', 'description': 'Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG003', 'title': 'Double Blind: JNJ-64565111 10.0 mg', 'description': 'Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG004', 'title': 'Open Label: Liraglutide 3.0 mg', 'description': 'Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}, {'value': '96', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 30', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who had received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '109', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Double Blind: Placebo', 'description': 'Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG001', 'title': 'Double Blind: JNJ-64565111 5.0 mg', 'description': 'Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG002', 'title': 'Double Blind: JNJ-64565111 7.4 mg', 'description': 'Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG003', 'title': 'Double Blind: JNJ-64565111 10.0 mg', 'description': 'Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG004', 'title': 'Open Label: Liraglutide 3.0 mg', 'description': 'Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26', 'description': 'Number of participants with \\>= 5% body weight loss from baseline to Week 26 were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '109', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Double Blind: Placebo', 'description': 'Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG001', 'title': 'Double Blind: JNJ-64565111 5.0 mg', 'description': 'Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG002', 'title': 'Double Blind: JNJ-64565111 7.4 mg', 'description': 'Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG003', 'title': 'Double Blind: JNJ-64565111 10.0 mg', 'description': 'Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG004', 'title': 'Open Label: Liraglutide 3.0 mg', 'description': 'Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26', 'description': 'Number of participants with \\>= 10 % body weight loss from baseline to Week 26 were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Double Blind: Placebo', 'description': 'Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG001', 'title': 'Double Blind: JNJ-64565111 5.0 mg', 'description': 'Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG002', 'title': 'Double Blind: JNJ-64565111 7.4 mg', 'description': 'Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG003', 'title': 'Double Blind: JNJ-64565111 10.0 mg', 'description': 'Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'OG004', 'title': 'Open Label: Liraglutide 3.0 mg', 'description': 'Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.05', 'spread': '0.827', 'groupId': 'OG000'}, {'value': '-9.58', 'spread': '0.861', 'groupId': 'OG001'}, {'value': '-11.07', 'spread': '0.633', 'groupId': 'OG002'}, {'value': '-13.23', 'spread': '0.656', 'groupId': 'OG003'}, {'value': '-8.32', 'spread': '0.610', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change from baseline in body weight at Week 26 was reported.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population. N (number of participants analyzed) = participants evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Double Blind: Placebo', 'description': 'Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'FG001', 'title': 'Double Blind: JNJ-64565111 5.0 mg', 'description': 'Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'FG002', 'title': 'Double Blind: JNJ-64565111 7.4 mg', 'description': 'Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'FG003', 'title': 'Double Blind: JNJ-64565111 10.0 mg', 'description': 'Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'FG004', 'title': 'Open Label: Liraglutide 3.0 mg', 'description': 'Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '118'}, {'groupId': 'FG003', 'numSubjects': '118'}, {'groupId': 'FG004', 'numSubjects': '119'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '104'}, {'groupId': 'FG003', 'numSubjects': '109'}, {'groupId': 'FG004', 'numSubjects': '115'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 474 participants were randomized out of which 444 participants completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}, {'value': '119', 'groupId': 'BG004'}, {'value': '474', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Double Blind: Placebo', 'description': 'Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'BG001', 'title': 'Double Blind: JNJ-64565111 5.0 mg', 'description': 'Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'BG002', 'title': 'Double Blind: JNJ-64565111 7.4 mg', 'description': 'Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'BG003', 'title': 'Double Blind: JNJ-64565111 10.0 mg', 'description': 'Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.'}, {'id': 'BG004', 'title': 'Open Label: Liraglutide 3.0 mg', 'description': 'Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.9', 'spread': '11.84', 'groupId': 'BG000'}, {'value': '47.3', 'spread': '11.18', 'groupId': 'BG001'}, {'value': '46.2', 'spread': '11.68', 'groupId': 'BG002'}, {'value': '46.2', 'spread': '12.16', 'groupId': 'BG003'}, {'value': '45.6', 'spread': '11.71', 'groupId': 'BG004'}, {'value': '46.3', 'spread': '11.73', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '89', 'groupId': 'BG004'}, {'value': '356', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '118', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}, {'value': '431', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}, {'value': '421', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'BELGIUM', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}]}]}, {'title': 'CANADA', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}]}]}, 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{'type': 'ACTUAL', 'count': 474}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-14', 'studyFirstSubmitDate': '2018-03-23', 'resultsFirstSubmitDate': '2020-01-14', 'studyFirstSubmitQcDate': '2018-03-30', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-14', 'studyFirstPostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Body Weight at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Week 30', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26', 'timeFrame': 'Week 26', 'description': 'Number of participants with \\>= 5% body weight loss from baseline to Week 26 were reported.'}, {'measure': 'Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26', 'timeFrame': 'Week 26', 'description': 'Number of participants with \\>= 10 % body weight loss from baseline to Week 26 were reported.'}, {'measure': 'Change From Baseline in Body Weight at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Change from baseline in body weight at Week 26 was reported.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo after 26 weeks of treatment on the percent change in body weight from baseline and to assess the safety and tolerability, in non-diabetic severely obese participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index (BMI) greater than or equal to (\\>=) 35 to less than or equal to (\\<=) 50 kilogram per square meter (kg/m\\^2) at the screening visit\n* Stable weight (that is, change of \\<= 5 percent \\[%\\] within 12 weeks before screening based on medical history)\n* Women must be either: (a) Postmenopausal, or (b) Permanently sterilized or otherwise be incapable of pregnancy, or (c) Heterosexually active and practicing a highly effective method of birth control, or (d) Not heterosexually active\n* Woman of childbearing potential have a negative pregnancy test at screening\n* Willing and able to adhere to specific the prohibitions and restrictions\n\nExclusion Criteria:\n\n* History of obesity with a known secondary cause (for example, Cushing's disease/syndrome)\n* History of Type 1 diabetes mellitus, Type 2 diabetes mellitus (T2DM), diabetic ketoacidosis (DKA), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy\n* Has a Hemoglobin A1c (HbA1c) of \\>= 6.5% or fasting plasma glucose (FPG) \\>= 126 milligrams per deciliter (mg/dL) (\\>= 7.0 millimoles per liter \\[mmol/L\\]) at screening\n* Screening calcitonin of \\>= 50 picograms per milliliter (pg/mL) personal history or family history of medullary thyroid cancer, or of multiple endocrine neoplasia syndrome type 2 (MEN 2), regardless of time prior to screening\n* History of glucagonoma"}, 'identificationModule': {'nctId': 'NCT03486392', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Randomized, Double-blind Placebo-controlled and Open-label Active-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Subjects', 'orgStudyIdInfo': {'id': 'CR108314'}, 'secondaryIdInfos': [{'id': '64565111OBE2001', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2017-003616-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Double-Blind: JNJ-64565111 Dose Level 1', 'description': 'Participants will receive a JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 26-week treatment phase.', 'interventionNames': ['Drug: JNJ-64565111 Dose Level 1']}, {'type': 'EXPERIMENTAL', 'label': 'Double-Blind: JNJ-64565111 Dose Level 2', 'description': 'Participants will receive a JNJ-64565111 Dose Level 2 SC once-weekly for 26-week treatment phase.', 'interventionNames': ['Drug: JNJ-64565111 Dose Level 2']}, {'type': 'EXPERIMENTAL', 'label': 'Double-Blind: JNJ-64565111 Dose Level 3', 'description': 'Participants will receive a JNJ-64565111 Dose Level 3 SC once-weekly for 26-week treatment phase.', 'interventionNames': ['Drug: JNJ-64565111 Dose Level 3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Double-Blind: Placebo', 'description': 'Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open-Label: 3.0 milligram (mg) Liraglutide', 'description': 'Participant will receive once-daily doses of 0.6, 1.2, 1.8, 2.4, or 3.0 mg. The participants will receive liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1. Participants will be instructed to increase the dose of liraglutide by 0.6 mg dose increment every 7 days, up to the full dosage of 3.0 mg by Week 5. 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