Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 6:06 AM
Study NCT ID:
NCT06354660
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2024-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic 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': 480}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Hemoglobin A1c (HbA1c) (%)', 'timeFrame': 'Baseline, Week 40'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieve HbA1c < 7.0%', 'timeFrame': 'Week 40'}, {'measure': 'Percentage of Participants Who Achieve HbA1c ≤ 6.5%', 'timeFrame': 'Week 40'}, {'measure': 'Percentage of Participants Who Achieve HbA1c < 5.7%', 'timeFrame': 'Week 40'}, {'measure': 'Change from Baseline in Fasting Serum Glucose', 'timeFrame': 'Baseline, Week 40'}, {'measure': 'Percent Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 40'}, {'measure': 'Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 40'}, {'measure': 'Percentage of Participants Who Achieve Weight Reduction of ≥ 5%', 'timeFrame': 'Week 40'}, {'measure': 'Percentage of Participants Who Achieve Weight Reduction of ≥ 10%', 'timeFrame': 'Week 40'}, {'measure': 'Percentage of Participants Who Achieve Weight Reduction of ≥ 15%', 'timeFrame': 'Week 40'}, {'measure': 'Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction', 'timeFrame': 'Week 40'}, {'measure': 'Percent Change from Baseline in Triglycerides', 'timeFrame': 'Baseline, Week 40'}, {'measure': 'Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol', 'timeFrame': 'Baseline, Week 40'}, {'measure': 'Change from Baseline in Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline, Week 40'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glucose Metabolism Disorders', 'Metabolic Diseases', 'Endocrine System Diseases'], 'conditions': ['Diabetes Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/472275', 'label': 'Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and inadequate glycemic control. The study will last about 11 months and may include up to 11 visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have Type 2 Diabetes (T2D)\n* Have HbA1c ≥ 7.0% to ≤ 9.5%\n* Are naïve to insulin therapy and have not used oral or injectable antihyperglycemic (diabetes) medication for at least 90 days prior to screening\n* Are of stable weight for at least 90 days prior to screening\n* Have a Body Mass Index (BMI) ≥ 23.0 kilograms per meter squared (kg/m\\^2)\n\nExclusion Criteria:\n\n* Have Type 1 Diabetes (T1D)\n* Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening\n* Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening\n* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema\n* Have an estimated glomerular filtration rate (eGFR) \\<15 milliliters/minute/1.73 meter squared (mL/min/1.73 m\\^2) as determined by the central laboratory\n* Have a prior or planned surgical treatment for obesity\n* Have New York Heart Association Functional Classification IV congestive heart failure\n* Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening\n* Have a known clinically significant gastric emptying abnormality\n* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years\n* Have any lifetime history of a suicide attempt\n* Had chronic or acute pancreatitis\n* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2\n* Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.'}, 'identificationModule': {'nctId': 'NCT06354660', 'briefTitle': 'Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Randomized, Multicenter, Double-Blind Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)', 'orgStudyIdInfo': {'id': '18804'}, 'secondaryIdInfos': [{'id': 'J1I-MC-GZBY', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retatrutide Dose Level 1', 'description': 'Participants will receive retatrutide administered subcutaneously (SC).', 'interventionNames': ['Drug: Retatrutide']}, {'type': 'EXPERIMENTAL', 'label': 'Retatrutide Dose Level 2', 'description': 'Participants will receive retatrutide administered SC.', 'interventionNames': ['Drug: Retatrutide']}, {'type': 'EXPERIMENTAL', 'label': 'Retatrutide Dose Level 3', 'description': 'Participants will receive retatrutide administered SC.', 'interventionNames': ['Drug: Retatrutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo administered SC.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Retatrutide', 'type': 'DRUG', 'otherNames': ['LY3437943'], 'description': 'Administered SC.', 'armGroupLabels': ['Retatrutide Dose Level 1', 'Retatrutide Dose Level 2', 'Retatrutide Dose Level 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Clinical Trials', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Clinical Research Institute', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91304', 'city': 'Canoga Park', 'state': 'California', 'country': 'United States', 'facility': 'San Fernando Valley Health Institute', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'zip': '90815', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Ark Clinical Research', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '32003', 'city': 'Fleming Island', 'state': 'Florida', 'country': 'United States', 'facility': 'Northeast Research Institute (NERI)', 'geoPoint': {'lat': 30.0933, 'lon': -81.71898}}, {'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'New Horizon Research Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Ezy Medical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33880', 'city': 'Winter Haven', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of Central Florida', 'geoPoint': {'lat': 28.02224, 'lon': -81.73286}}, {'zip': '30064', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Trinity Research Centers', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': "Cotton O'Neil Clinical Research Center", 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '02721', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'NECCR PrimaCare Research', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '63005', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinical Research Professionals', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '59804', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Boeson Research MSO', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '07036', 'city': 'Linden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'NJ MedCare & NJ Heart', 'geoPoint': {'lat': 40.62205, 'lon': -74.24459}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Accellacare - Wilmington - 1917 Tradd Court', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '45439', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Providence Health Partners-Center for Clinical Research', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '19114', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Research of Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15401', 'city': 'Uniontown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Preferred Primary Care Physicians', 'geoPoint': {'lat': 39.90008, 'lon': -79.71643}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Delricht Research - Tobias Gadson Boulevard - Charleston', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38115', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Lifedoc Research - Lenox Park Drive', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Research Associates Inc', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Velocity Clinical Research, Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75028', 'city': 'Flower Mound', 'state': 'Texas', 'country': 'United States', 'facility': 'Prime Revival Research Institute, LLC', 'geoPoint': {'lat': 33.01457, 'lon': -97.09696}}, {'zip': '76164', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Valley Institute of Research - Fort Worth', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78231', 'city': 'Shavano Park', 'state': 'Texas', 'country': 'United States', 'facility': 'Consano Clinical Research, LLC', 'geoPoint': {'lat': 29.58495, 'lon': -98.55252}}, {'zip': '78596', 'city': 'Weslaco', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Valley Clinical Research', 'geoPoint': {'lat': 26.15952, 'lon': -97.99084}}, {'zip': '20110', 'city': 'Manassas', 'state': 'Virginia', 'country': 'United States', 'facility': 'Manassas Clinical Research Center', 'geoPoint': {'lat': 38.75095, 'lon': -77.47527}}, {'zip': '99004', 'city': 'Cheney', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Rockwood Cheney Clinic', 'geoPoint': {'lat': 47.48739, 'lon': -117.57576}}, {'zip': '98052', 'city': 'Redmond', 'state': 'Washington', 'country': 'United States', 'facility': 'Eastside Research Associates', 'geoPoint': {'lat': 47.67399, 'lon': -122.12151}}, {'zip': '492099', 'city': 'Raipur', 'state': 'Chhattisgarh', 'country': 'India', 'facility': 'All India Institute of Medical Sciences', 'geoPoint': {'lat': 21.23333, 'lon': 81.63333}}, {'zip': '380052', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Gujarat Endocrin Pvt Ltd', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '395002', 'city': 'Surat', 'state': 'Gujarat', 'country': 'India', 'facility': 'Nirmal Hospital Pvt Ltd.', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '560002', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Victoria Hospital, Bangalore Medical College And Research Institute', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '673008', 'city': 'Kozhikode', 'state': 'Kerala', 'country': 'India', 'facility': 'Government Medical College - Kozhikode', 'geoPoint': {'lat': 11.24802, 'lon': 75.7804}}, {'zip': '751019', 'city': 'Bhubaneswar', 'state': 'Odisha', 'country': 'India', 'facility': 'All India Institute of Medical Sciences', 'geoPoint': {'lat': 20.27241, 'lon': 85.83385}}, {'zip': '302020', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Eternal Heart Care Center and Research Institute', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '208020', 'city': 'Kanpur', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Brij Medical Centre Private Limited', 'geoPoint': {'lat': 26.46523, 'lon': 80.34975}}, {'zip': '42000', 'city': 'Pachuca', 'state': 'Hidalgo', 'country': 'Mexico', 'facility': 'Grupo Ollin Care', 'geoPoint': {'lat': 20.11697, 'lon': -98.73329}}, {'zip': '04460', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Instituto Jalisciense de Investigacion en Diabetes y Obesidad', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '14080', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Unidad biomedica avanzada monterrey', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '64610', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Clínica García Flores SC', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '66465', 'city': 'San Nicolás de los Garza', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Centro de investigación y control metabólico', 'geoPoint': {'lat': 25.74167, 'lon': -100.30222}}, {'zip': '97000', 'city': 'Mérida', 'state': 'Yucatán', 'country': 'Mexico', 'facility': 'EME RED Hospitalaria', 'geoPoint': {'lat': 20.967, 'lon': -89.62318}}, {'zip': '97070', 'city': 'Mérida', 'state': 'Yucatán', 'country': 'Mexico', 'facility': 'Medical Care and Research SA de CV', 'geoPoint': {'lat': 20.967, 'lon': -89.62318}}, {'zip': '91910', 'city': 'Veracruz', 'country': 'Mexico', 'facility': 'Arké SMO S.A de C.V', 'geoPoint': {'lat': 19.18095, 'lon': -96.1429}}, {'zip': '00646', 'city': 'Dorado', 'country': 'Puerto Rico', 'facility': 'Dorado Medical Complex', 'geoPoint': {'lat': 18.45883, 'lon': -66.26767}}, {'zip': '00716', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'Ponce Medical School Foundation Inc.', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}], '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 or 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'}}}}