Not recruiting

Study on the Effects of Retatrutide for Patients with Severe Obesity and Cardiovascular Disease

Verified siteInvestigational

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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 on individuals with obesity and cardiovascular disease. Retatrutide, also known by its code name LY3437943, is given as a solution for injection under the skin. The study aims to evaluate how effective and safe Retatrutide is when administered once a week to participants who have both obesity and established heart disease.

Participants in the study will receive either Retatrutide or a placebo injection. The study will monitor changes in body weight and assess the overall health and safety of the participants throughout the trial. The goal is to understand how Retatrutide can help manage weight and improve health outcomes in people with these conditions.

The study will take place over a period of time, during which participants will receive regular injections and attend follow-up visits to track their progress. The information gathered from this study will contribute to understanding the potential benefits of Retatrutide for individuals with obesity and cardiovascular disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to receive either the study medication, Retatrutide, or a placebo. A placebo is an inactive substance that looks like the study medication but does not contain the active ingredient.
Step 2
Medication administration
You will receive the medication as a subcutaneous injection, which means it is injected under the skin. This will be done once a week.
The medication is provided as a solution for injection.
Step 3
Monitoring and follow-up
Throughout the study, your health will be monitored regularly to assess the efficacy and safety of the treatment. This includes checking for any changes in your body weight and overall health condition.
Regular follow-up visits will be scheduled to ensure your well-being and to collect necessary data for the study.
Step 4
Study duration
The study is expected to continue until February 17, 2026. Your participation will involve regular visits and adherence to the study protocol until the end of the study period.

Who can join the trial?

5 criteria

Must have obesity.
Must have established heart disease.
Must have a history of unsuccessful attempts to lose weight through diet.
Open to both men and women.
Participants from vulnerable populations are included. This means people who might need extra protection or care.

Who cannot join the trial?

3 criteria

Having a medical condition other than **Cardiovascular Disease** or **Obesity**.
Being outside the age range specified for the study.
Being part of a vulnerable population that the study does not include.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centrum Badan Klinicznych Pi-House Sp. z o.o.
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Gdansk, Poland
Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Verified
Lleida, Spain

Trial locations

Where you can join this trial

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Investigated drugs

Retatrutide is a medication being studied for its potential to help people with severe obesity who also have heart disease. It is given once a week and is designed to help reduce body weight. The study aims to see how well it works and how safe it is for people with these health conditions. Retatrutide works by affecting certain hormones in the body that are involved in regulating appetite and metabolism, which may help people lose weight and improve their heart health.

Ly3437943 Sodium

What is already known about the treatment

Retatrutide – Retatrutide is administered as an injection given once a week, designed to help people with severe obesity and cardiovascular disease. It is currently being studied in clinical trials to assess its effectiveness and safety for these conditions. The medication works by targeting specific pathways in the body that regulate appetite and metabolism, helping to reduce weight and improve heart health. Retatrutide is classified as a medication that influences metabolic processes, aiming to support weight loss and cardiovascular health.

Investigated diseases

Cardiovascular Disease
Cardiovascular disease refers to a group of disorders affecting the heart and blood vessels. It often begins with damage to the blood vessels, leading to the buildup of fatty deposits, known as plaques, which can narrow or block arteries. This process, called atherosclerosis, can progress over time and may result in reduced blood flow to the heart or brain. As the disease advances, it can lead to conditions such as coronary artery disease, heart attack, or stroke. The progression of cardiovascular disease can be influenced by factors like high blood pressure, high cholesterol, smoking, and diabetes. It is a chronic condition that can develop over many years.
Obesity
Obesity is a medical condition characterized by an excessive accumulation of body fat. It develops when the intake of calories exceeds the amount of energy expended over time, leading to weight gain. This condition can progress gradually, often starting with overweight and advancing to obesity as body mass index (BMI) increases. Obesity can lead to various health complications, including increased risk for type 2 diabetes, cardiovascular disease, and certain cancers. The progression of obesity is influenced by factors such as genetics, lifestyle, diet, and physical activity levels. It is a chronic condition that can have significant impacts on overall health and well-being.