Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-02 @ 12:49 AM
Study NCT ID:
NCT05929066
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-18
First Post:
2023-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China', 'South Korea', 'Taiwan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], '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'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, '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': 2300}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2023-06-26', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Body Weight', 'timeFrame': 'Baseline, Week 80'}, {'measure': 'Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset', 'timeFrame': 'Baseline, Week 80'}, {'measure': 'Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset', 'timeFrame': 'Baseline, Week 80'}, {'measure': 'Percent Change from Baseline in Body Weight to', 'timeFrame': 'Baseline, Week 104'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Body Mass Index (BMI)', 'timeFrame': 'Baseline, Week 80'}, {'measure': 'Change from Baseline in Waist Circumference', 'timeFrame': 'Baseline, Week 80'}, {'measure': 'Change from Baseline in Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline, Week 80'}, {'measure': 'Percent Change form Baseline in Fasting Insulin', 'timeFrame': 'Baseline, Week 80'}, {'measure': 'Change from Baseline in HbA1c', 'timeFrame': 'Baseline, Week 80'}, {'measure': 'Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score', 'timeFrame': 'Baseline, Week 80'}, {'measure': 'Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)', 'timeFrame': 'Baseline through Week 80', 'description': 'AUC is presented as a single average measure of AUC across the study duration.'}, {'measure': 'Change from Baseline in the WOMAC Physical Function Subscale Score for GOA1 Subset', 'timeFrame': 'Baseline, Week 80'}, {'measure': 'Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score for GOA1 Subset', 'timeFrame': 'Baseline, Week 80'}, {'measure': 'Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score for GOA1 Subset', 'timeFrame': 'Baseline, Week 80'}, {'measure': 'Percent Change from Baseline in AHI for GSA1 Subset', 'timeFrame': 'Baseline, Week 80'}, {'measure': 'A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 Score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score for GSA1 Subset', 'timeFrame': 'Baseline to Week 80', 'description': 'A hierarchical combination of change from baseline in the FOSQ 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score will be assessed by the win ratio. The reported unit will be the total "wins" for each treatment group from performing a hierarchical comparison of the components.'}, {'measure': 'Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA1 Subset', 'timeFrame': 'Baseline to Week 80'}, {'measure': 'Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA1 Subset', 'timeFrame': 'Week 80'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight', 'Osteoarthritis, Knee', 'Obstructive Sleep Apnea']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/408235', 'label': 'A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight (TRIUMPH-1)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following:\n\n * hypertension\n * dyslipidemia\n * obstructive sleep apnea, or\n * cardiovascular disease\n* History of of at least one unsuccessful dietary effort to reduce body weight\n\nGOA1 Inclusion Criteria:\n\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\nGSA1 Inclusion Criteria:\n\n* Previously diagnosed with OSA\n* Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)\n* For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening.\n* If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.\n\nGZBJ Addenda (2) inclusion criteria:\n\n* Have completed the final treatment visit of GZBJ Week 80.\n\nExclusion Criteria:\n\n* Have a self-reported or documented change in body weight \\>5 kg (11 pounds) within 90 days.\n* Have taken 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.\n* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)\n* Have had pancreatitis.\n\nGOA1 exclusion 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\nGSA1 exclusion criteria\n\n* Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening.\n* Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening.\n* Use a dental appliance or other device to treat OSA other than PAP therapy.\n\nGZBJ Addenda (2) exclusion criteria\n\n* Have had study intervention discontinuation.\n* Have had permanent dose reduction.'}, 'identificationModule': {'nctId': 'NCT05929066', 'acronym': 'TRIUMPH-1', 'briefTitle': 'A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-1)', 'orgStudyIdInfo': {'id': '18557'}, 'secondaryIdInfos': [{'id': 'J1I-MC-GZBJ', 'type': 'OTHER', 'domain': 'Master Protocol Eli Lilly and Company'}, {'id': 'J1I-MC-GOA1', 'type': 'OTHER', 'domain': 'ISA Eli Lilly and Company'}, {'id': 'J1I-MC-GSA1', 'type': 'OTHER', 'domain': 'ISA Eli Lilly and Company'}, {'id': '2023-503657-35-00', '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': 'EXPERIMENTAL', 'label': 'Retatrutide Dose 3', 'description': 'Participants will receive retatrutide SC.', 'interventionNames': ['Drug: Retatrutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Retatrutide Extension Period', 'description': 'Participants will receive retatrutide after the placebo-controlled 80 week treatment period for an additional 24 weeks.', 'interventionNames': ['Drug: Retatrutide']}], 'interventions': [{'name': 'Retatrutide', 'type': 'DRUG', 'otherNames': ['LY3437943'], 'description': 'Administered SC', 'armGroupLabels': ['Retatrutide Dose 1', 'Retatrutide Dose 2', 'Retatrutide Dose 3', 'Retatrutide Extension Period']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 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