Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
Study NCT ID:
NCT05035095
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2021-08-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 667}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'dispFirstSubmitDate': '2024-03-14', 'completionDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2021-08-30', 'studyFirstSubmitQcDate': '2021-08-30', 'dispFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative change in body weight', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'percentage-point'}, {'measure': 'Achievement of body weight reduction greater than or equal to 5% (Yes/No)', 'timeFrame': 'At end-of-treatment (week 68)', 'description': 'Count of participants'}], 'secondaryOutcomes': [{'measure': 'Achievement of body weight reduction greater than or equal to 10% (Yes/No)', 'timeFrame': 'At end of treatment (week 68)', 'description': 'Count of participants'}, {'measure': 'Change in Short Form-36 (SF-36) Physical Function', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'Score points'}, {'measure': 'Change in IWQOL-Lite-CT Physical Function', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'Score points'}, {'measure': 'Change in waist circumference', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'measured in cm'}, {'measure': 'Achievement of body weight reduction greater than or equal to 15% (Yes/No)', 'timeFrame': 'At end of treatment (week 68)', 'description': 'Count of participants'}, {'measure': 'Achievement of body weight reduction greater than or equal to 20% (Yes/No)', 'timeFrame': 'At end of treatment (week 68)', 'description': 'Count of participants'}, {'measure': 'Change in body mass index (BMI)', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'measured in kg/m\\^2'}, {'measure': 'Change in systolic blood pressure', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'measured in mmHg'}, {'measure': 'Change in diastolic blood pressure', 'timeFrame': 'From randomisation (week 0) to end of treatment (week 68)', 'description': 'measured in mmHg'}, {'measure': 'Change in HbA1c (glycated haemoglobin)', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'percentage-point'}, {'measure': 'Change in fasting plasma glucose (FPG)', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'measured in mg/dL'}, {'measure': 'Change in fasting serum insulin', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'Ratio to baseline'}, {'measure': 'Change in lipids: Total cholesterol', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'Ratio to baseline'}, {'measure': 'Change in lipids: HDL (high density lipoprotein) cholesterol', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'Ratio to baseline'}, {'measure': 'Change in lipids: LDL (low-density lipoprotein) cholesterol', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'Ratio to baseline'}, {'measure': 'Change in lipids: VLDL (very-low density lipoprotein) cholesterol', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'Ratio to baseline'}, {'measure': 'Change in lipids: Triglycerides', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'Ratio to baseline'}, {'measure': 'Change in lipids: Free fatty acids', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'Ratio to baseline'}, {'measure': 'Change in high sensitivity C-Reactive Protein', 'timeFrame': 'From baseline (week 0) to end of treatment (week 68)', 'description': 'Ratio to baseline'}, {'measure': 'Number of treatment emergent adverse events', 'timeFrame': 'From baseline (week 0) to end-of-trial (week 75)', 'description': 'Count of events'}, {'measure': 'Number of serious adverse events', 'timeFrame': 'From baseline (week 0) to end-of-trial (week 75)', 'description': 'Count of events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '37385278', 'type': 'BACKGROUND', 'citation': 'Knop FK, Aroda VR, do Vale RD, Holst-Hansen T, Laursen PN, Rosenstock J, Rubino DM, Garvey WT; OASIS 1 Investigators. Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Aug 26;402(10403):705-719. doi: 10.1016/S0140-6736(23)01185-6. Epub 2023 Jun 26.'}]}, 'descriptionModule': {'briefSummary': "This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight.\n\nThis study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation.\n\nSemaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes.\n\nParticipants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning\n\nIn addition to taking the medicine, participants will have talks with study staff about:\n\n* healthy food choices\n* how to be more physically active\n* what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits.\n\nParticipants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age greater than or equal to 18 years at the time of signing informed consent\n* Body mass index (BMI):\n\ngreater than or equal to 27.0 kg/m\\^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease OR greater than or equal to 30.0 kg/m\\^2\n\n* History of at least one self-reported unsuccessful dietary effort to lose body weight\n\nExclusion Criteria:\n\n* HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening\n* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records'}, 'identificationModule': {'nctId': 'NCT05035095', 'acronym': 'OASIS 1', 'briefTitle': 'Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)', 'orgStudyIdInfo': {'id': 'NN9932-4737'}, 'secondaryIdInfos': [{'id': 'U1111-1253-1670', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': '2020-002953-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral semaglutide', 'description': 'Participants will receive once daily semaglutide tables in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68)', 'interventionNames': ['Drug: Oral semaglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Oral semaglutide placebo', 'description': 'All participants are given once daily dose for 68 weeks', 'interventionNames': ['Drug: Placebo (semaglutide)']}], 'interventions': [{'name': 'Oral semaglutide', 'type': 'DRUG', 'description': 'Participants will receive a daily dose of oral semaglutide.', 'armGroupLabels': ['Oral semaglutide']}, {'name': 'Placebo (semaglutide)', 'type': 'DRUG', 'description': 'Oral placebo (semaglutide) once daily. Planned treatment duration will be 68 weeks.', 'armGroupLabels': ['Oral semaglutide placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Univ of Alabama Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clin Res Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '34744', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'The Chappel Group Research', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Trial Res Assoc,Inc', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'East West Med Res Inst', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Inst For Clin Res', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Clinical Research, Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Accellacare', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '19104-3317', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The University of Penn Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Velocity Clinical Res-Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22206', 'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'facility': 'Washington Cntr Weight Mgmt', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}, {'zip': '22601-3834', 'city': 'Winchester', 'state': 'Virginia', 'country': 'United States', 'facility': 'Selma Medical Associates', 'geoPoint': {'lat': 39.18566, 'lon': -78.16333}}, {'zip': '98502', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'facility': 'Capital Clin Res Ctr,LLC', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}, {'zip': 'V3Z 2N6', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Ocean West Research Clinic', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'E1G 1A7', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'G.A. 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