Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
Study NCT ID:
NCT06859268
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-16
First Post:
2025-02-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C000729679', 'term': 'retatrutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase 3b'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 643}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2025-02-28', 'studyFirstSubmitQcDate': '2025-02-28', 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change from Baseline in Body Weight', 'timeFrame': 'Week 0, Week 116'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Waist Circumference', 'timeFrame': 'Week 0, Week 116'}, {'measure': 'Percentage of Body Weight Reduction Achieved at Week 80 that is Maintained at Week 116', 'timeFrame': 'Week 0, Week 80, Week 116'}, {'measure': 'Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)', 'timeFrame': 'Week 0, Week 116'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/580035', 'label': 'A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals with Obesity (TRIUMPH-6)'}]}, 'descriptionModule': {'briefSummary': 'This is a study of retatrutide in participants with obesity. The main purpose is to learn more about how retatrutide maintains body weight loss. The study will have two treatment phases: an 80 week lead-in phase in which all participants will take retatrutide dose 1 and a 36 week randomized, double-blinded phase in which participants will either take retatrutide dose 1, retatrutide dose 2, or switch to placebo. Participation in the study will last around 125 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight\n\nExclusion Criteria:\n\n* Have a self-reported change in body weight \\>5 kilograms (kg) (11 pounds) within 90 days before screening\n* Have a prior or planned surgical treatment for obesity\n* Have a prior or planned endoscopic procedure and/or device-based therapy for obesity\n* Have Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes\n* Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)\n* Have had within the past 90 days before screening:\n\n * acute myocardial infarction\n * cerebrovascular accident (stroke)\n * hospitalization for unstable angina, or\n * hospitalization due to congestive heart failure\n* Have New York Heart Association Functional Classification Class IV congestive heart failure\n* Have a history of chronic or acute pancreatitis\n* Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening'}, 'identificationModule': {'nctId': 'NCT06859268', 'acronym': 'TRIUMPH-6', 'briefTitle': 'A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Retatrutide Treatment in the Maintenance of Weight Reduction in Individuals With Obesity', 'orgStudyIdInfo': {'id': '27268'}, 'secondaryIdInfos': [{'id': 'J1I-MC-GZQB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retatrutide Dose 1', 'description': 'Participants will receive retatrutide dose 1 administered subcutaneously (SC) for 116 weeks', 'interventionNames': ['Drug: Retatrutide']}, {'type': 'EXPERIMENTAL', 'label': 'Retatrutide Dose 1 to Retatrutide Dose 2', 'description': 'Participants will receive retatrutide dose 1 administered SC for 80 weeks, then retatrutide dose 2 administered SC for an additional 36 weeks', 'interventionNames': ['Drug: Retatrutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Retatrutide Dose 1 to Placebo', 'description': 'Participants will receive retatrutide dose 1 administered SC for 80 weeks, then placebo administered SC for an additional 36 weeks', 'interventionNames': ['Drug: Retatrutide', 'Drug: Placebo']}], 'interventions': [{'name': 'Retatrutide', 'type': 'DRUG', 'otherNames': ['LY3437943'], 'description': 'Administered SC', 'armGroupLabels': ['Retatrutide Dose 1', 'Retatrutide Dose 1 to Placebo', 'Retatrutide Dose 1 to Retatrutide Dose 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Retatrutide Dose 1 to Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92701', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Clinical Research', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06517', 'city': 'Hamden', 'state': 'Connecticut', 'country': 'United States', 'facility': 'CMR of Greater New Haven, LLC', 'geoPoint': {'lat': 41.39593, 'lon': -72.89677}}, {'zip': '33024', 'city': 'Cooper City', 'state': 'Florida', 'country': 'United States', 'facility': 'ALL Medical Research, LLC', 'geoPoint': {'lat': 26.05731, 'lon': -80.27172}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida International Medical Research', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '34470', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Renstar Medical Research', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Charter Research - 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Mauricie inc.', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}, {'zip': 'B21 9RY', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'FutureMeds - Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BB2 1AX', 'city': 'Blackburn', 'country': 'United Kingdom', 'facility': 'Oakenhurst Medical Practice', 'geoPoint': {'lat': 53.75, 'lon': -2.48333}}, {'zip': 'FY3 7EN', 'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Layton Medical Centre', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'zip': 'BA15 1DQ', 'city': 'Bradford-on-Avon', 'country': 'United Kingdom', 'facility': 'Bradford on Avon Health Centre', 'geoPoint': {'lat': 51.34772, 'lon': -2.25065}}, {'zip': 'CH62 6EE', 'city': 'Bromborough', 'country': 'United Kingdom', 'facility': 'FutureMeds - Liverpool', 'geoPoint': {'lat': 53.3485, 'lon': -2.97935}}, {'zip': 'ST10 1NS', 'city': 'Cheadle', 'country': 'United Kingdom', 'facility': 'Cheadle Community Hospital', 'geoPoint': {'lat': 52.98333, 'lon': -1.98333}}, {'zip': 'TW4 7NR', 'city': 'Hounslow', 'country': 'United Kingdom', 'facility': 'HMC Health Group - Meadows Centre for Health', 'geoPoint': {'lat': 51.46839, 'lon': -0.36092}}, {'zip': 'OX4 1XB', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': "St Bartholomew's Medical Centre", 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'TR18 3DX', 'city': 'Penzance', 'country': 'United Kingdom', 'facility': 'Atlantic Medical', 'geoPoint': {'lat': 50.11861, 'lon': -5.53715}}, {'zip': 'BH16 5PW', 'city': 'Poole', 'country': 'United Kingdom', 'facility': 'The Adam Practice', 'geoPoint': {'lat': 50.71429, 'lon': -1.98458}}, {'zip': 'S61 1AH', 'city': 'Rotherham', 'country': 'United Kingdom', 'facility': 'Woodstock Bower Surgery', 'geoPoint': {'lat': 53.43012, 'lon': -1.35678}}, {'zip': 'PL11 2TB', 'city': 'Torpoint', 'country': 'United Kingdom', 'facility': 'Rame Group Practice', 'geoPoint': {'lat': 50.37505, 'lon': -4.19566}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}