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 study about?

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.

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 baseline measurements

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

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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional	Sevilla	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Clinico Universitario De Valencia	Valencia	Spain
Universita’ Di Pisa	Pisa	Italy
Centro Cardiologico Monzino S.p.A.	Milan	Italy
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Alyjtaq Oyuhywtbgll Paks Gentgjzg Xdxbf	Bergamo	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	15.11.2023
Spain	Not recruiting	15.11.2023

Trial locations

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.

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 ID:

2023-504583-42-00

Protocol code:

J1I-MC-GZBU

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?