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 Sex
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

More Details

NCT ID
NCT05536804
Status
Active, not recruiting
Sponsor
Eli Lilly and Company

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.