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Study of Tirzepatide and Placebo for People with Overweight or Obesity and 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 medication called tirzepatide on individuals who have Chronic Kidney Disease (CKD) and are either overweight or have Obesity. Some participants may also have Type 2 Diabetes (T2D). The study aims to understand how tirzepatide, which is given as a solution for injection, affects kidney health, particularly the oxygen levels in the kidneys, over a period of 52 weeks. A placebo will also be used for comparison.

The trial will involve participants with and without Type 2 Diabetes to see how the medication works in different groups. The main focus is on kidney oxygenation, which will be measured using a special imaging technique called Magnetic Resonance Imaging (MRI). This technique helps to visualize the blood oxygen levels in the kidneys, providing insights into how the kidneys are functioning.

Participants will receive either tirzepatide or a placebo and will be monitored over the course of the study to assess changes in their kidney health. The study is designed to provide valuable information on the potential benefits of tirzepatide for people with kidney issues related to being overweight or having Obesity, with or without Type 2 Diabetes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. This study focuses on the effects of the medication tirzepatide on kidney function in individuals with overweight or obesity and chronic kidney disease, with or without type 2 diabetes.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your current health status. This may include physical examinations, blood tests, and imaging studies to establish a baseline for your kidney function.

  3. Step 3

    Medication administration

    You will receive the medication tirzepatide as a solution for injection under the skin (subcutaneous injection). The dosage will be determined by the study team and administered once a week for a duration of 52 weeks.

  4. Step 4

    Regular monitoring

    Throughout the study, regular monitoring will be conducted to assess your response to the medication. This will include scheduled visits for blood tests, imaging studies, and other assessments as required by the study protocol.

  5. Step 5

    Final assessment

    At the end of the 52-week treatment period, a final assessment will be conducted to evaluate changes in your kidney function. This will involve similar tests and examinations as the initial assessment.

  6. Step 6

    Study completion

    Upon completion of the study, you will receive information about the overall findings and any relevant results pertaining to your participation. Further follow-up may be discussed based on your health status and study outcomes.

Who can join the trial?

5 criteria

  • Must have obesity or be overweight. This means having a body weight that is higher than what is considered healthy for a certain height.
  • Must have chronic kidney disease. This is a condition where the kidneys are damaged and cannot filter blood as well as they should.
  • Half of the participants must have type 2 diabetes, and half must not have it. Type 2 diabetes is a condition that affects how the body processes blood sugar.
  • Both men and women can participate.
  • Participants from vulnerable populations are included. This means people who might need special care or protection.

Who cannot join the trial?

20 criteria

  • Having a history of severe allergic reactions to any of the study medications.
  • Currently participating in another clinical trial.
  • Having a medical condition that the study doctor believes would make it unsafe to participate.
  • Pregnant or planning to become pregnant during the study period.
  • Breastfeeding during the study period.
  • Having a history of drug or alcohol abuse within the past year.
  • Having a significant heart condition that is not well controlled.
  • Having uncontrolled high blood pressure.
  • Having a history of cancer within the past 5 years, except for certain types of skin cancer.
  • Having a history of liver disease.
  • Having a history of pancreatitis, which is inflammation of the pancreas.
  • Having a history of certain types of eye problems related to diabetes.
  • Having a history of certain types of stomach or intestinal problems.
  • Having a history of certain types of nerve problems.
  • Having a history of certain types of blood disorders.
  • Having a history of certain types of kidney problems.
  • Having a history of certain types of thyroid problems.
  • Having a history of certain types of mental health conditions.
  • Having a history of certain types of autoimmune diseases.
  • Having a history of certain types of infections.
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Investigated drugs

Tirzepatide is a medication being studied for its effects on kidney function in people who are overweight or have obesity, and who also have chronic kidney disease. It is also being looked at in people with or without type 2 diabetes. The main goal of using tirzepatide in this study is to see how it affects the amount of oxygen in the kidneys after a year of treatment. This medication is given once a week and is being compared to a placebo to understand its potential benefits on kidney health.

What is already known about the treatment

Tirzepatide – Tirzepatide is administered as a weekly injection under the skin, and it is currently being studied for its effects on kidney function in people who are overweight or obese and have chronic kidney disease, with or without type 2 diabetes. This medication is primarily indicated for managing chronic kidney disease, type 2 diabetes, obesity, and overweight conditions. At the molecular level, tirzepatide works by mimicking hormones that help regulate blood sugar and appetite, which can improve kidney health and reduce weight. It is classified as a dual agonist, targeting specific receptors involved in glucose and energy regulation.

Investigated diseases

  • Chronic Kidney Disease

    Chronic Kidney Disease is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. This disease progresses through stages, starting with mild damage and potentially advancing to severe kidney failure. As the disease progresses, waste products can build up in the body, leading to symptoms like fatigue, swelling, and high blood pressure. The progression can be slow, often taking years to reach advanced stages. It can affect various bodily functions, including fluid balance, electrolyte levels, and red blood cell production.

  • Type 2 Diabetes

    Type 2 Diabetes 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 effectively to insulin, and eventually, the pancreas may not produce enough insulin. Over time, high blood sugar levels can lead to various complications affecting the heart, kidneys, nerves, and eyes. The progression of Type 2 Diabetes can be gradual, often starting with prediabetes, where blood sugar levels are higher than normal but not yet high enough to be classified as diabetes. Lifestyle factors, such as diet and physical activity, play a significant role in its development and progression.

  • Obesity

    Obesity is a condition characterized by excessive body fat accumulation that may impair health. It is typically measured using the Body Mass Index (BMI), with a BMI of 30 or higher indicating obesity. The condition can develop over time due to factors like poor diet, lack of physical activity, genetics, and certain medical conditions. As obesity progresses, it can lead to various health issues, including cardiovascular diseases, Type 2 Diabetes, and joint problems. The accumulation of fat, particularly around the abdomen, is associated with increased health risks.

  • Overweight

    Overweight is a condition where an individual has more body weight than is considered healthy for their height, often due to excess body fat. It is typically assessed using the Body Mass Index (BMI), with a BMI between 25 and 29.9 indicating overweight. The condition can develop gradually due to factors such as poor diet, lack of physical activity, and genetic predisposition. Being overweight can increase the risk of developing health problems like cardiovascular diseases, Type 2 Diabetes, and certain cancers. The progression from being overweight to obesity can occur if lifestyle factors contributing to weight gain are not addressed.

Trial detailsLast updated 12 Nov 2026
Age18+ yearsPhasePhase IITrial ID2023-506082-60-00Protocol codeI8F-MC-GPIGEstimated enrolment140 patientsSponsorEli Lilly & Co.

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