Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-27 @ 12:48 PM
Study NCT ID:
NCT06297603
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)
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'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'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': 320}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2024-03-01', 'studyFirstSubmitQcDate': '2024-03-01', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Hemoglobin A1c (HbA1c) (%)', 'timeFrame': 'Baseline, Week 52'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving HbA1c <7.0%', 'timeFrame': 'Week 52'}, {'measure': 'Percentage of Participants Achieving HbA1c ≤6.5%', 'timeFrame': 'Week 52'}, {'measure': 'Change from Baseline in Fasting Serum Glucose', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL', 'timeFrame': 'Week 52', 'description': 'Measured during the CGM session that occurs during 30 days prior to Week 52'}, {'measure': 'Percent Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Percentage of Participants Achieving Weight Reduction of ≥5%', 'timeFrame': 'Week 52'}, {'measure': 'Percentage of Participants Achieving Weight Reduction of ≥10%', 'timeFrame': 'Week 52'}, {'measure': 'Percentage of Participants Achieving Weight Reduction of ≥15%', 'timeFrame': 'Week 52'}, {'measure': 'Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction', 'timeFrame': 'Week 52'}, {'measure': 'Percent Change from Baseline in Non-HDL Cholesterol', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Percent Change from Baseline in Triglycerides', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Change from Baseline in Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline, Week 52'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glucose Metabolism Disorders', 'Metabolic Diseases', 'Endocrine System Diseases', 'Diabetes Mellitus', 'Diabetes Mellitus, Type 2', 'Kidney Disease', 'Renal Insufficiency Chronic'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/466881', 'label': 'Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)'}]}, '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 renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 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% (53 millimoles per mole (mmol/mol)) to ≤10.5% (91 mmol/mol)\n* Have moderate or severe renal impairment\n* Have been on the following stable diabetes treatment during 90 days prior to screening\n\n * basal insulin (≥20 International Units (IU)/day) with or without\n * metformin and/or SGLT2 inhibitor\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/m2)\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 a history of unstable or rapidly progressing renal disease\n* Have a prior or planned surgical treatment for obesity\n* Have New York Heart Association Functional Classification III or IV congestive heart failure\n* Have had 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 a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.\n* Have any lifetime history of a suicide attempt\n* Had chronic or acute pancreatitis\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': 'NCT06297603', 'briefTitle': 'Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)', '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, Moderate or Severe Renal Impairment With Inadequate Glycemic Control on Basal Insulin With or Without Metformin and/or SGLT2 Inhibitor', 'orgStudyIdInfo': {'id': '18806'}, 'secondaryIdInfos': [{'id': 'J1I-MC-GZQA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retatrutide Dose 1', 'description': 'Participants will receive retatrutide administered subcutaneously (SC).', 'interventionNames': ['Drug: Retatrutide']}, {'type': 'EXPERIMENTAL', 'label': 'Retatrutide Dose 2', 'description': 'Participants will receive retatrutide administered SC.', 'interventionNames': ['Drug: Retatrutide']}, {'type': 'EXPERIMENTAL', 'label': 'Retatrutide Dose 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 1', 'Retatrutide Dose 2', 'Retatrutide Dose 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Nephrology Consultants', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85375', 'city': 'Sun City West', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Research Institute of Arizona (CRI) - Sun City West', 'geoPoint': {'lat': 33.66198, 'lon': -112.34127}}, {'zip': '92307', 'city': 'Apple Valley', 'state': 'California', 'country': 'United States', 'facility': 'Kidney & Hypertension Center - Apple Valley', 'geoPoint': {'lat': 34.50083, 'lon': -117.18588}}, {'zip': '91303', 'city': 'Canoga Park', 'state': 'California', 'country': 'United States', 'facility': 'Hope Clinical Research, Inc.', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Neighborhood Healthcare Institute of Health', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'EndoTrials Center for Clinical Research', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'UCLA South Bay Endocrinology', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '32003', 'city': 'Fleming Island', 'state': 'Florida', 'country': 'United States', 'facility': 'Northeast Research Institute (NERI)', 'geoPoint': {'lat': 30.0933, 'lon': -81.71898}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Encore Medical Research - 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Fri 8 AM - 8 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 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'}}}}