Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-07 @ 11:07 AM
Study NCT ID:
NCT05931367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-22
First Post:
2023-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, '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': 'C000729679', 'term': 'retatrutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 405}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2023-06-27', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score', 'timeFrame': 'Baseline, Week 68'}, {'measure': 'Percent Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 68'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in the WOMAC Physical Function Subscale Score', 'timeFrame': 'Baseline, Week 68'}, {'measure': 'Change from Baseline in Waist Circumference', 'timeFrame': 'Baseline, Week 68'}, {'measure': 'Percent Change from Baseline in Total Cholesterol', 'timeFrame': 'Baseline, Week 68'}, {'measure': 'Percent Change from Baseline in Triglycerides', 'timeFrame': 'Baseline, Week 68'}, {'measure': 'Change from Baseline in Body Mass Index (BMI)', 'timeFrame': 'Baseline, Week 68'}, {'measure': 'Change from Baseline in Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline, Week 68'}, {'measure': 'Change from Baseline in Diastolic Blood Pressure (DBP)', 'timeFrame': 'Baseline, Week 68'}, {'measure': 'Percent Change from Baseline in Fasting Insulin', 'timeFrame': 'Baseline, Week 68'}, {'measure': 'Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score', 'timeFrame': 'Baseline, Week 68'}, {'measure': 'Change from Baseline in Average Pain Intensity Numeric Rating Score (API-NRS) Score', 'timeFrame': 'Baseline, Week 68'}, {'measure': 'Change from Baseline in Worst Pain Intensity Numeric Rating Score (WPI-NRS) Score', 'timeFrame': 'Baseline, Week 68'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight', 'Osteo Arthritis Knee']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/408355', 'label': 'A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee (TRIUMPH-4)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and efficacy of retatrutide once-weekly in participants who have obesity or are overweight and have osteoarthritis (OA) of the knee. The study will lasts about 77 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a body mass index (BMI) ≥27 kilogram/kg/m² at screening.\n* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.\n* Have index knee pain for \\>12 weeks prior to screening, and presence of index knee pain for \\>15 days over the previous month.\n* Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening.\n* Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.\n\nExclusion Criteria:\n\n* Have had steroid joint injections within 90 days of screening.\n* Have had other joint injections and procedures within 6 months of screening.\n* Have joint disease other than osteoarthritis.\n* Have a self-reported or documented change in body weight \\>5 kg (11 pounds) within 90 days prior to screening.\n* Have been taking weight loss drugs, including over-the-counter medications, within 90 days prior to screening.\n* Have a prior or planned surgical treatment for obesity.\n* Have diabetes mellitus.'}, 'identificationModule': {'nctId': 'NCT05931367', 'acronym': 'TRIUMPH-4', 'briefTitle': 'A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '18583'}, 'secondaryIdInfos': [{'id': 'J1I-MC-GZBN', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2023-503660-17-00', 'type': 'OTHER', 'domain': 'EU Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retatrutide Dose 1', 'description': 'Participants will receive retatrutide subcutaneously (SC).', 'interventionNames': ['Drug: Retatrutide']}, {'type': 'EXPERIMENTAL', 'label': 'Retatrutide Dose 2', 'description': 'Participants will receive retatrutide SC.', 'interventionNames': ['Drug: Retatrutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Retatrutide', 'type': 'DRUG', 'otherNames': ['LY3437943'], 'description': 'Administered SC', 'armGroupLabels': ['Retatrutide Dose 1', 'Retatrutide Dose 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': 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'Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': 'LE5 4PW', 'city': 'Leicester', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'Leicester General Hospital', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'EN3 4GS', 'city': 'Enfield', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Panthera Biopartners - North London', 'geoPoint': {'lat': 51.65147, 'lon': -0.08497}}, {'zip': 'S2 5FX', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Panthera Biopartners - Sheffield', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], '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': 'http://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 European Union (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'}}}}