Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-05 @ 7:49 PM
Study NCT ID:
NCT05936151
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2023-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729679', 'term': 'retatrutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Phase 2b'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2023-06-30', 'studyFirstSubmitQcDate': '2023-06-30', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Glomerular Filtration Rate (mGFR)', 'timeFrame': 'Baseline, Week 24', 'description': 'The GFR in milliliter/minute per1.73 square meter (mL/min/1.73 m²) using iohexol clearance (mGFR-measured glomerular filtration rate)'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Urine Albumin-to-Creatinine Ratio (UACR)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in Creatinine-Corrected Fractional Urinary Sodium Excretion (FENa)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in Filtration Fraction Estimated from Measured Glomerular Filtration Rate (mGFR)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in Renal Mean Arterial Flow as Assessed by Magnetic Resonance Imaging (MRI), Corrected by Hematocrit', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in in Mean Arterial Flow (MAF)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in Renal Artery Resistive Index (RARI)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in Renal Blood Flow Velocity Peak Systolic Velocity (PSV) and End-diastolic Velocity (ESV)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in Global Renal Perfusion (MRI)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in Total Renal Parenchyma Volume (MRI)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in Renal Cortex Volume (MRI)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in Renal Cortex T1 (ms) (MRI)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in Medulla T1 (ms) (MRI)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in Renal Cortex R2 (BOLD MRI)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in Medulla R2', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in 24-hr Urinary Albumin Excretion (UAE)', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change from Baseline in Change in 24-hour (hr) Urinary Electrolytes (milligrams/24hr (mg/24h))', 'timeFrame': 'Baseline, Week 24'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight or Obesity', 'CKD', 'Type 2 Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/410437.', 'label': 'A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to investigate the effect of retatrutide on renal function in participants with overweight or obesity and chronic kidney disease (CKD), with or without Type 2 Diabetes (T2D). The study will last around 31 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/square meter (kg/m²)\n* Have either\n\n * no T2D with an HbA1c \\< 6.5% or\n * have T2D with an HbA1c ≤ 9.5% and treated with diet and exercise only or with stable doses of up to 3 oral antihyperglycemic medications, with or without basal insulin for at least 90 days before screening.\n* Have been diagnosed with chronic kidney disease (CKD).\n\nExclusion Criteria:\n\n* Have a self-reported change in body weight \\>5 kilogram (kg) (11 pounds) within 90 days before screening.\n* Have used in 90 days before the screening any of the following antihyperglycemic class: Dipeptidyl Peptidase IV (DPP4) inhibitors, amylin analogs, glucagon-like peptide-RA (GLP-RA), gastric inhibitory polypeptide (GIP)/GIP-1 RA, and short acting or rapid acting insulins or U500 Insulin\n* Have a prior or planned surgical treatment for obesity\n* Have Type 1 Diabetes (T1D)\n* Have acute or chronic hepatitis\n* Have a history of malignant disease within 5 years before screening.'}, 'identificationModule': {'nctId': 'NCT05936151', 'briefTitle': 'A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 2b, Double-Blind Study to Investigate the Effect of Retatrutide on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes', 'orgStudyIdInfo': {'id': '18725'}, 'secondaryIdInfos': [{'id': 'J1I-MC-GZBU', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2023-504583-42-00', 'type': 'OTHER', 'domain': 'EU Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retatrutide', 'description': 'Participants will receive multiple doses of retatrutide subcutaneously (SC)', 'interventionNames': ['Drug: Retatrutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive LY3437943', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Retatrutide', 'type': 'DRUG', 'otherNames': ['LY3437943'], 'description': 'Administered SC', 'armGroupLabels': ['Retatrutide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85225', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'The Institute for Liver Health II dba Arizona Clinical Trials - 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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'}}}}