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HomeTrials › NCT05536804

Obesity & weight · Phase 2 · Active, not recruiting

A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

NCT05536804 · Sponsor: Eli Lilly and Company

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Tirzepatide, Placebo for overweight, obesity, chronic kidney disease.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeTirzepatide, Placebo
Study length~3.6 years overall
Planned participants140
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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). The study will last about 56 weeks and include up to 12 visits.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

Inclusion Criteria: All participants with or without diabetes: * Have a Body Mass Index (BMI) ≥27 kilogram/square meter (kg/m²) at screening * Diagnosed with chronic kidney disease (CKD) * 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) * 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) Participants without diabetes: * Have Hemoglobin A1c (HbA1c) \<6.5% at screening Participants with Type 2 diabetes: * Have been diagnosed at least 180 days prior to screening * Have HbA1c ≤9.5% at screening Exclusion Criteria: All participants: * Have a self-reported change in body weight \>5 kilogram (kg) within 90 days prior to screening. * Have a prior or planned surgical treatment for obesity * Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 180 days * 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. * Have a history of unstable or rapidly progressing renal disease according to investigator judgment * 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) * Have had a history of chronic or acute pancreatitis Participants with T2D: * Have history of proliferative diabetic retinopathy or diabetic macular edema or non-proliferative diabetic retinopathy that requires acute treatment. * Have been diagnosed with type 1 diabetes (T1D) or have history of ketoacidosis or hyperosmolar state/coma

Study sites by state

California

  • Valley Clinical Trials, Inc. — Northridge

Colorado

  • University of Colorado Anschutz Medical Campus — Aurora
  • Kidney Associates of Colorado — Denver

Indiana

  • American Health Network of Indiana, LLC - Avon — Avon
  • American Health Network of Indiana, LLC - Greenfield — Greenfield
  • Indiana University Health University Hospital — Indianapolis
  • American Health Network of Indiana, LLC - Muncie — Muncie

Michigan

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy

Washington

  • University of Washington Medical Center - Montlake — Seattle
  • Providence Medical Research Center - Spokane — Spokane

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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