Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tirzepatide
Tirzepatide administered subcutaneously (SC)
  • Drug: Tirzepatide
    Administered SC
Placebo Comparator
Placebo
Placebo administered SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

Valley Clinical Trials, Inc.
Northridge, California 91325
Contact:
818-280-4220

University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045

Kidney Associates of Colorado
Denver, Colorado 80210

American Health Network of Indiana, LLC - Avon
Avon, Indiana 46123
Contact:
317-718-5479

American Health Network of Indiana, LLC - Greenfield
Greenfield, Indiana 46140
Contact:
317-462-1825

Indiana University Health University Hospital
Indianapolis, Indiana 46202

American Health Network of Indiana, LLC - Muncie
Muncie, Indiana 47304
Contact:
317-462-1825

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan 48098
Contact:
248-312-0025

University of Washington Medical Center - Montlake
Seattle, Washington 98195

Providence Medical Research Center - Spokane
Spokane, Washington 99204
Contact:
509-474-4345

More Details

NCT ID
NCT05536804
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1877-285-4559) or
1-317-615-4559
clinical_inquiry_hub@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.