Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-28 @ 3:36 PM
Study NCT ID:
NCT05536804
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2022-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Tirzepatide (LY3298176) 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': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney 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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'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': 'D000098860', 'term': 'Tirzepatide'}], 'ancestors': [{'id': 'D000067757', 'term': 'Glucagon-Like Peptide-1 Receptor'}, {'id': 'D000067756', 'term': 'Glucagon-Like Peptide Receptors'}, {'id': 'D043562', 'term': 'Receptors, G-Protein-Coupled'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011964', 'term': 'Receptors, Gastrointestinal Hormone'}, {'id': 'D018000', 'term': 'Receptors, Peptide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2022-09-09', 'studyFirstSubmitQcDate': '2022-09-09', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Kidney Oxygenation in Participants With or Without T2D', 'timeFrame': 'Baseline, Week 52', 'description': 'Blood oxygenation-level dependent magnetic resonance imaging (BOLD MRI)'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Kidney Oxygenation in Participants with T2D (BOLD MRI)', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Change from Baseline in Kidney Oxygenation in Participants without T2D (BOLD MRI)', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Percent Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Percent Change from Baseline in Renal Sinus Fat Content (MRI)', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Percent Change from Baseline in Renal Fat Content (MRI Proton Density Fat Fraction)', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Percent Change from Baseline in Renal Blood Flow (Phase-Contrast MRI)', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Change from Baseline in Apparent Diffusion Coefficient (ADC) MRI', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Change from Baseline in Glomerular Filtration Rate (GFR) Iohexol Clearance in Milliliter/Minute/Square Meter (ml/min/m²)', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Change from Baseline in 24-hour Urinary Albumin Excretion (UAE) in Milligram/24 Hours (mg/24h)', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Percent Change from Baseline in Urine Albumin-to-Creatine Ratio (UACR)', 'timeFrame': 'Baseline, Week 52'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight', 'Obesity', 'Chronic Kidney Disease', 'Type 2 Diabetes', 'T2D']}, 'referencesModule': {'references': [{'pmid': '40512543', 'type': 'DERIVED', 'citation': 'Heerspink HJL, Friedman AN, Bjornstad P, van Raalte DH, Cherney D, Cao D, Garcia-Perez LE, Stefanski A, Turfanda I, Bunck MC, Benabbad I, Griffin R, Piras de Oliveira C. Kidney Parameters with Tirzepatide in Obesity with or without Type 2 Diabetes. J Am Soc Nephrol. 2025 Nov 1;36(11):2190-2200. doi: 10.1681/ASN.0000000764. Epub 2025 Jun 13.'}, {'pmid': '39963952', 'type': 'DERIVED', 'citation': 'Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.'}], 'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/360461', 'label': 'A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes (TREASURE-CKD)'}]}, 'descriptionModule': {'briefSummary': 'We are doing this study to learn more about how tirzepatide may help fight chronic kidney disease in people with obesity with or without type 2 diabetes (T2D).\n\nThe study will last about 56 weeks and include up to 12 visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll participants with or without diabetes:\n\n* Have a Body Mass Index (BMI) ≥27 kilogram/square meter (kg/m²) at screening\n* Diagnosed with chronic kidney disease (CKD)\n* Has an estimated glomerular filtration rate (eGFR) ≥25 to ≤60 ml/min/1.73 m² or eGFR ≥25 to ≤75 ml/min/1.73 m² if urine albumin-to-creatinine ratio (UACR) \\>30 milligram/gram (mg/g)\n* Have been receiving an angiotensin-converting enzyme (ACE) or angiotensin II receptor blockers (ARB) that is considered the maximal appropriate dose by the investigator for treatment of chronic kidney disease or hypertension (unless the participant has low blood pressure or hypotension)\n\nParticipants without diabetes:\n\n* Have Hemoglobin A1c (HbA1c) \\<6.5% at screening\n\nParticipants with Type 2 diabetes:\n\n* Have been diagnosed at least 180 days prior to screening\n* Have HbA1c ≤9.5% at screening\n\nExclusion Criteria:\n\nAll participants:\n\n* Have a self-reported change in body weight \\>5 kilogram (kg) within 90 days prior to screening.\n* Have a prior or planned surgical treatment for obesity\n* Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 180 days\n* Have eGFR \\<25 mL/min/1.73m² calculated by using creatinine-based chronic kidney disease epidemiology collaboration (CKD-EPI) equations, as determined by central laboratory at screening.\n* Have a history of unstable or rapidly progressing renal disease according to investigator judgment\n* Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility)\n* Have had a history of chronic or acute pancreatitis\n\nParticipants with T2D:\n\n* Have history of proliferative diabetic retinopathy or diabetic macular edema or non-proliferative diabetic retinopathy that requires acute treatment.\n* Have been diagnosed with type 1 diabetes (T1D) or have history of ketoacidosis or hyperosmolar state/coma'}, 'identificationModule': {'nctId': 'NCT05536804', 'acronym': 'TREASURE-CKD', 'briefTitle': 'A Study of Tirzepatide (LY3298176) 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': 'Tirzepatide Study of Renal Function in People With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes: Focus on Kidney Hypoxia in Relation to Fatty Kidney Disease Using Multiparametric Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': '17217'}, 'secondaryIdInfos': [{'id': 'I8F-MC-GPIG', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2021-005273-47', 'type': 'EUDRACT_NUMBER'}, {'id': '2023-506082-60-00', 'type': 'OTHER', 'domain': 'EU Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tirzepatide', 'description': 'Tirzepatide administered subcutaneously (SC)', 'interventionNames': ['Drug: Tirzepatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered SC', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tirzepatide', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Tirzepatide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Valley Clinical Trials, Inc.', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Kidney Associates of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '46123', 'city': 'Avon', 'state': 'Indiana', 'country': 'United States', 'facility': 'American Health Network of Indiana, LLC - Avon', 'geoPoint': {'lat': 39.76282, 'lon': -86.39972}}, {'zip': '46140', 'city': 'Greenfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'American Health Network of Indiana, LLC - Greenfield', 'geoPoint': {'lat': 39.78504, 'lon': -85.76942}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '47304', 'city': 'Muncie', 'state': 'Indiana', 'country': 'United States', 'facility': 'American Health Network of Indiana, LLC - Muncie', 'geoPoint': {'lat': 40.19338, 'lon': -85.38636}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Arcturus Healthcare , PLC, Troy Internal Medicine Research Division', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center - Montlake', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Medical Research Center - Spokane', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '1030', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Klinik Landstraße', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1060', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Zentrum für klinische Studien Dr Hanusch Gmbh', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Klinik Hietzing', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'L4N 7L3', 'city': 'Barrie', 'country': 'Canada', 'facility': 'LMC Clinical Research Inc. (Barrie)', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'L4K 4M2', 'city': 'Concord', 'country': 'Canada', 'facility': 'LMC Clinical Research Inc. (Thornhill)', 'geoPoint': {'lat': 43.80011, 'lon': -79.48291}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'country': 'Canada', 'facility': "Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire -T", 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N2J 1C4', 'city': 'Waterloo', 'country': 'Canada', 'facility': 'Fadia El Boreky Medicine', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus Universitetshospital, Skejby', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '06700', 'city': 'Cuauhtémoc', 'country': 'Mexico', 'facility': 'Centro de Investigación y Gastroenterología', 'geoPoint': {'lat': 19.44506, 'lon': -99.14612}}, {'zip': '62448', 'city': 'Cuernavaca', 'country': 'Mexico', 'facility': 'Investigación Nefrológica', 'geoPoint': {'lat': 18.9261, 'lon': -99.23075}}, {'zip': '03100', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Health Pharma Professional Research S.A. de C.V:', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '03310', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Grupo Medico Camino Sc', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '06760', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Caimed Investigacion En Salud S.A. de C.V.', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '14080', 'city': 'México', 'country': 'Mexico', 'facility': 'Instituto Nacional de Cardiologia Ignacio Chavez', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '7609 PP', 'city': 'Almelo', 'country': 'Netherlands', 'facility': 'Ziekenhuisgroep Twente, locatie Almelo', 'geoPoint': {'lat': 52.35667, 'lon': 6.6625}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam UMC, locatie VUmc', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], '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'}}}}