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

• Status: Not yet recruiting
• Trial end date: 2025-11-07
• Target enrollment: 0
• Participant gender: All

Summary

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 1 year.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Tirzepatide

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) ≥30 to ≤60 ml/min/1.73 m² or eGFR ≥30 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 ≥7.0% to ≤10.5% 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 <30 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