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Using tirzepatide to treat obesity and chronic kidney disease in patients with or without diabetes

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

Phase 2 Interventional Eli Lilly and Company · NCT05536804

This study tests whether the medication tirzepatide can help people with obesity and chronic kidney disease, with or without diabetes, improve their kidney function and overall health.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment140 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations27 sites (Northridge, California and 26 other locations)
Trial IDNCT05536804 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of tirzepatide on individuals with overweight or obesity who also have chronic kidney disease, with or without type 2 diabetes. Participants will receive either tirzepatide or a placebo over a period of approximately 56 weeks, with up to 12 visits for monitoring and assessment. The goal is to determine how tirzepatide may help improve kidney function and overall health in this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults with a BMI of 27 or higher who have chronic kidney disease and may have type 2 diabetes.

Not a fit: Patients who have experienced significant weight changes recently or have severe kidney impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for managing chronic kidney disease in patients with obesity.

How similar studies have performed: While similar studies have explored treatments for obesity and chronic kidney disease, the specific use of tirzepatide in this context is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Northridge, California and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions OverweightObesityChronic Kidney DiseaseType 2 DiabetesT2D
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.