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Study on Retatrutide and Placebo for Kidney Function in Overweight or Obese Patients with Chronic Kidney Disease, with or without Type 2 Diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment called Retatrutide (also known by its code name LY3437943) on kidney function in people who are either overweight or have obesity, and who also have Chronic Kidney Disease (CKD). Some participants may also have Type 2 Diabetes, but it is not a requirement for all. The study aims to understand how this treatment affects the kidneys over a period of time.

Participants in the study will receive either the treatment Retatrutide or a placebo, which is a substance with no active medication. The study will last for several weeks, during which participants will receive injections of the treatment or placebo. The main goal is to observe any changes in kidney function, specifically looking at a measure called the glomerular filtration rate (GFR), which indicates how well the kidneys are filtering blood. To measure this, a substance called iohexol will be used, which helps in assessing kidney function.

The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, ensuring unbiased results. The trial will help determine if Retatrutide can improve kidney function in individuals with CKD, with or without Type 2 Diabetes, who are also dealing with being overweight or obesity.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the participant is overweight or has obesity, has chronic kidney disease (CKD), and may or may not have Type 2 diabetes.

    Participants with Type 2 diabetes should be managing it with diet, exercise, and stable doses of up to three oral diabetic medications.

  2. Step 2

    Baseline measurements

    Baseline measurements are taken to establish initial health parameters. This includes measuring the glomerular filtration rate (GFR) using iohexol clearance.

  3. Step 3

    Medication administration

    Participants receive either Retatrutide (LY3437943) or a placebo as a solution for injection. The specific dosage and frequency are determined by the study protocol.

  4. Step 4

    Ongoing monitoring

    Throughout the study, participants are monitored regularly to assess the effect of the medication on renal function. This includes periodic measurements of GFR and other relevant health indicators.

  5. Step 5

    Final assessment

    At the end of the 24-week period, a final assessment is conducted to evaluate changes in renal function from baseline. This involves repeating the GFR measurement using iohexol clearance.

Who can join the trial?

5 criteria

  • Must be overweight.
  • Must either not have Type 2 diabetes or have it and be managing it with diet and exercise, possibly with stable doses of up to three oral diabetes medications.
  • Must have been diagnosed with Chronic Kidney Disease (CKD), which is a long-term condition where the kidneys do not work as well as they should.
  • Both men and women can participate.
  • Participants can be from a vulnerable population, which means they might need extra protection or care.

Who cannot join the trial?

10 criteria

  • Patients who are pregnant or breastfeeding cannot participate.
  • Individuals with a history of severe allergic reactions to the study medication are excluded.
  • Patients with uncontrolled high blood pressure are not eligible.
  • Individuals with a recent history of heart attack or stroke cannot join the study.
  • Patients with severe liver disease are excluded.
  • Individuals who have participated in another clinical trial within the last 30 days are not eligible.
  • Patients with a history of drug or alcohol abuse in the past year cannot participate.
  • Individuals with certain types of cancer are excluded.
  • Patients with a history of organ transplant are not eligible.
  • Individuals with any other medical condition that the study doctors believe would make participation unsafe are excluded.
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Investigated drugs

LY3437943 is a medication being studied for its potential effects on kidney function. It is being tested in people who are overweight or have obesity and also have chronic kidney disease, with or without type 2 diabetes. The main goal of the study is to see how this medication affects kidney function over a 24-week period.

What is already known about the treatment

LY3437943 – This medication is administered via injection and is currently being studied in clinical trials to assess its effects on kidney function in individuals with overweight or obesity and chronic kidney disease, with or without type 2 diabetes. It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication is to improve renal function in the specified patient group. At the molecular level, LY3437943 is believed to work by modulating pathways involved in kidney health, although the exact mechanism is still being researched. It falls under the pharmacological classification of investigational drugs.

Investigated diseases

  • Overweight or Obesity

    This condition is characterized by an excessive accumulation of body fat, which may impair health. It typically develops when calorie intake exceeds calorie expenditure over time. Overweight and obesity are often measured using the Body Mass Index (BMI), a ratio of weight to height. These conditions can lead to increased stress on the body, affecting various systems such as the cardiovascular and musculoskeletal systems. They may also contribute to the development of other health issues, including type 2 diabetes and heart disease. Lifestyle factors, genetics, and environmental influences can all play a role in the development of overweight and obesity.

  • Chronic Kidney Disease

    This is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. It often progresses slowly over time and can be caused by conditions such as diabetes and high blood pressure. As kidney function declines, waste products can build up in the body, leading to symptoms like fatigue, swelling, and changes in urination. The disease is typically divided into stages based on the level of kidney function, with early stages often showing few symptoms. Over time, chronic kidney disease can affect other body systems, including the cardiovascular system. Management focuses on slowing the progression and addressing underlying causes.

  • Type 2 Diabetes

    This is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin, and eventually, the pancreas may not produce enough insulin. This leads to elevated blood sugar levels, which can cause symptoms such as increased thirst, frequent urination, and fatigue. Over time, high blood sugar can damage various organs and systems, including the heart, blood vessels, nerves, eyes, and kidneys. Lifestyle factors, genetics, and environmental factors can contribute to the development of type 2 diabetes.

Trial detailsLast updated 24 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504583-42-00Protocol codeJ1I-MC-GZBUEstimated enrolment120 patientsSponsorEli Lilly & Co.

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