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Evaluating the effects of retatrutide on heart and kidney health in adults with obesity

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and Major Adverse Kidney Events in Participants With Body Mass Index ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

Phase 3 Interventional Eli Lilly and Company · NCT06383390

This study is testing if a weekly injection of retatrutide can help improve heart and kidney health in adults with obesity who have heart or kidney problems.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment10000 (estimated)
Ages45 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations844 sites (Alabaster, Alabama and 843 other locations)
Trial IDNCT06383390 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess whether retatrutide, administered once weekly, can reduce serious cardiovascular complications and prevent kidney function deterioration in adults with obesity. The study will enroll participants with a body mass index of 27 kg/m² or higher who have established atherosclerotic cardiovascular disease or chronic kidney disease. Over approximately five years, participants will attend up to 27 clinic visits to monitor their health outcomes. The trial will compare the effects of retatrutide against a placebo.

Who should consider this trial

Good fit: Ideal candidates include adults with a body mass index of 27 kg/m² or higher who have atherosclerotic cardiovascular disease and/or chronic kidney disease.

Not a fit: Patients with Type 1 diabetes or those with uncontrolled Type 2 diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve cardiovascular and kidney health for patients living with obesity.

How similar studies have performed: Other studies have shown promising results with similar interventions targeting cardiovascular and kidney outcomes in patients with obesity.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants may be without type 2 diabetes (T2D), or with T2D if their hemoglobin A1c (HbA1c) is 10% or lower
* Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD), as evidenced at least one of the following:

  * Coronary artery disease
  * Cerebrovascular disease
  * Peripheral arterial disease
  * Chronic kidney disease defined as:

    * eGFR \<45 millilitres/minute/1.73 meter squared (mL/min/1.73m\^2) and UACR \>30 milligram/gram (mg/g) (0.030 mg/mg)
    * eGFR \<60 mL/min/1.73 m\^2 and UACR \>100 mg/g (0.100 mg/mg), or
    * eGFR \<75 mL/min/1.73 m\^2 and UACR \>300 mg/g (0.300 mg/mg) (eGFR is calculated by central lab based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine-cystatin c equation as determined by central lab)
* A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m\^2)

Exclusion Criteria:

Diabetes related:

* Participants have Type 1 Diabetes or any history of diabetic ketoacidosis

CV related:

* Participants have any of the following cardiovascular conditions ≤ 90 days prior to randomization:

  * Myocardial infarction
  * Acute coronary syndrome
  * Stroke, or
  * Coronary, peripheral, or carotid artery arterial revascularization procedure.
* Have acute decompensated heart failure requiring hospitalization.
* Have New York Heart Association (NYHA) Classification Class IV heart failure at screening

Kidney related:

* Participants have an eGFR \<20 mL/min/1.73 m\^2 at screening
* Have UACR \>5000 mg/g (5.000 mg/mg) at screening
* Have received any form of dialysis ≤ 90 days from the date of randomization
* Have either undergone a kidney transplant or have a transplant procedure scheduled

Other medical conditions:

* Participants have had or plan to have a surgical treatment for obesity,
* Have a history of chronic or acute pancreatitis
* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2
* Have a known clinically significant gastric emptying abnormality, such as severe gastroparesis or gastric outlet obstruction

Where this trial is running

Alabaster, Alabama and 843 other locations

+794 more sites — see ClinicalTrials.gov for the full list.

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 Atherosclerotic Cardiovascular DiseaseChronic Kidney DiseaseCardiovascular DiseaseKidney DiseaseMajor Adverse Cardiovascular EventsRenal OutcomesCardiovascular Risk ReductionKidney Disease Progression
Last reviewed 2026-06-10 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.