Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2026-03-22 @ 7:57 AM
Study NCT ID:
NCT03842202
Status:
COMPLETED
Last Update Posted:
2020-12-24
First Post:
2019-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sponsor staff involved in the clinical trial is masked according to company standard procedures.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-22', 'studyFirstSubmitDate': '2019-02-13', 'studyFirstSubmitQcDate': '2019-02-13', 'lastUpdatePostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-5h,para: the area under the paracetamol concentration-time curve from 0 to 5 hours at steady state', 'timeFrame': '0 to 5 hours after standardised meal (day 142)', 'description': 'Measured in h\\*micrograms/mL'}], 'secondaryOutcomes': [{'measure': 'AUC0-1h,para: the area under the paracetamol concentration-time curve from 0 to 1 hour at steady state', 'timeFrame': '0 to 1 hour after standardised meal (day 142)', 'description': 'Measured in h\\*micrograms/mL'}, {'measure': 'Cmax,para: the maximum observed paracetamol concentration from 0 to 5 hours', 'timeFrame': '0 to 5 hours after standardised meal (day 142)', 'description': 'Measured in micrograms/mL'}, {'measure': 'Tmax,para: the time of maximum observed paracetamol concentration from 0 to 5 hours', 'timeFrame': '0 to 5 hours after standardised meal (day 142)', 'description': 'Measured in hours'}, {'measure': 'Energy intake during ad libitum lunch', 'timeFrame': 'Day 142', 'description': 'Measured in kilojoules'}, {'measure': 'Mean postprandial rating - Hunger (AUC30-300min/270 min) using visual analogue scales (VAS) from 30 up to 300 minutes during standardised breakfast meal', 'timeFrame': 'Day 142', 'description': 'Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.'}, {'measure': 'Mean postprandial rating - Fullness (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal', 'timeFrame': 'Day 142', 'description': 'Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.'}, {'measure': 'Mean postprandial rating - Satiety (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal', 'timeFrame': 'Day 142', 'description': 'Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.'}, {'measure': 'Mean postprandial rating - Prospective food consumption (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal', 'timeFrame': 'Day 142', 'description': 'Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.'}, {'measure': 'Mean postprandial rating - Overall appetite score (OAS) (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal', 'timeFrame': 'Day 142', 'description': 'Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '33269530', 'type': 'RESULT', 'citation': 'Friedrichsen M, Breitschaft A, Tadayon S, Wizert A, Skovgaard D. The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. Diabetes Obes Metab. 2021 Mar;23(3):754-762. doi: 10.1111/dom.14280. Epub 2021 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'This study will look at how the emptying of the participant\'s stomach after a meal is affected by semaglutide (a new medicine) compared to a "dummy" medicine. In addition, the study will also look at the effect of semaglutide on the participant\'s appetite and energy intake. Participants will either get semaglutide or "dummy" medicine - which treatment any participant gets is decided by chance. Participants will take 1 injection per week. The study medicine is injected with a thin needle in the stomach, thigh or upper arm. The study will last for about 27 weeks (from first treatment to last check-up). Participants will have 8 visits at the clinic with the study doctor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, aged between 18 to 65 years (both inclusive) at the time of signing informed consent\n* Body mass index (BMI) between 30.0 and 45.0 kg/m\\^2 (both inclusive)\n\nExclusion criteria:\n\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method\n* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol\n* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions"}, 'identificationModule': {'nctId': 'NCT03842202', 'briefTitle': 'A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Effect of Semaglutide 2.4 mg Once-weekly on Gastric Emptying in Subjects With Obesity', 'orgStudyIdInfo': {'id': 'NN9536-4455'}, 'secondaryIdInfos': [{'id': 'U1111-1215-9915', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': '2018-002497-42', 'type': 'REGISTRY', 'domain': 'European Medicines Agency (EudraCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semaglutide', 'description': 'Participants will receive increasing doses of semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks.', 'interventionNames': ['Drug: Semaglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Semaglutide)', 'description': 'Participants will receive placebo (semaglutide). The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Semaglutide', 'type': 'DRUG', 'description': 'Participants will receive gradually increasing doses of semaglutide (subcutaneous \\[s.c.\\], in the thigh, abdomen or upper arm) injection once weekly, until they reach a dose of level of 2.4 mg, which they will continue for 5 weeks.', 'armGroupLabels': ['Semaglutide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive once weekly injections of semaglutide matched placebo.', 'armGroupLabels': ['Placebo (Semaglutide)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Clinical Reporting Anchor and Disclosure (1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}