Overview

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