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Study Comparing Retatrutide and Tirzepatide for Weight Loss in Adults with Obesity

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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 effectiveness and safety of two medications, Retatrutide and Tirzepatide, in adults who have obesity. Obesity is a condition characterized by excessive body weight that may affect overall health. The purpose of the study is to determine if Retatrutide is more effective than Tirzepatide in helping participants lose weight.

Participants in the study will receive either Retatrutide or Tirzepatide, both of which are given as a solution for injection under the skin, known as a subcutaneous injection. The study will compare the changes in body weight from the beginning to the end of the study period. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know which medication each participant is receiving, to ensure unbiased results.

The study will take place over a period of time, during which participants will be monitored for changes in their body weight and any side effects they may experience. The goal is to provide valuable information on the potential benefits and safety of these medications for individuals with obesity, ultimately contributing to better treatment options in the future.

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, the participant will be randomly assigned to receive either retatrutide or tirzepatide. Both medications are administered as a solution for injection under the skin, known as a subcutaneous injection.
Step 2
Medication administration
The participant will receive the assigned medication, either retatrutide or tirzepatide, through subcutaneous injections. The specific dosage and frequency will be determined by the study protocol, which aims to evaluate the effectiveness and safety of these medications in reducing body weight.
Step 3
Monitoring and assessments
Throughout the study, the participant's body weight will be regularly monitored to assess the percent change from the baseline. This is the primary endpoint of the study, which means it is the main outcome being measured to determine the effectiveness of the treatment.
Step 4
Completion of the study
The study is estimated to conclude by November 16, 2026. At the end of the study, the collected data will be analyzed to compare the effectiveness of retatrutide and tirzepatide in achieving weight loss in adults with obesity.

Who can join the trial?

4 criteria

Must have obesity, which means having a body weight that is higher than what is considered healthy for a given height.
Must have tried at least once to lose weight through diet but did not succeed.
Both men and women can participate.
Participants can be from a vulnerable population, which means they might need extra care or protection.

Who cannot join the trial?

8 criteria

Individuals who are not within the specified age range for the study.
Individuals who do not have a diagnosis of obesity.
Individuals who are part of a vulnerable population that the study is not designed to include.
Individuals who are not able to comply with the study requirements or procedures.
Individuals who have any medical condition or are taking any medication that could interfere with the study results.
Individuals who are pregnant or planning to become pregnant during the study period.
Individuals who have participated in another clinical trial recently.
Individuals who have a history of allergic reactions to the study medications.

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Verified sites

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

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Ambenet GmbH Das Ambulante Behandlungsnetz
Leipzig, Germany
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Medizentrum Essen Borbeck
Essen, Germany
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Uniwersytecki Szpital Kliniczny W Bialymstoku
Bialystok, Poland

Trial locations

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Investigated drugs

Retatrutide
is a medication being studied to see if it can help reduce body weight in adults who have obesity. It is being compared to another medication to determine its effectiveness and safety in helping people lose weight.
Tirzepatide
is another medication used in the study to help reduce body weight in adults with obesity. It serves as a comparison to evaluate the effectiveness of retatrutide in achieving weight loss.

What is already known about the treatment

Retatrutide
Retatrutide is administered via injection and is currently being studied in clinical trials for its effectiveness in treating obesity. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for retatrutide is weight loss in individuals with obesity. It works by targeting specific receptors in the body to regulate appetite and metabolism, helping to reduce body weight. Retatrutide is classified as a weight management medication.
Tirzepatide
Tirzepatide is also administered through injection and is being compared to retatrutide in clinical trials for obesity treatment. It is already known in the medical field for its role in managing blood sugar levels in type 2 diabetes, but its use for weight loss is still being explored. The primary therapeutic indication in this trial is to aid in weight reduction for those with obesity. Tirzepatide functions by mimicking hormones that regulate insulin and appetite, promoting weight loss. It is classified as a dual agonist for weight management and diabetes control.

Investigated diseases

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may negatively impact health. It develops when there is an imbalance between calories consumed and calories expended, leading to weight gain. Over time, this excess weight can strain the body's systems, potentially leading to various health issues. The progression of obesity can vary, with some individuals experiencing gradual weight gain over years, while others may see more rapid changes. Factors such as genetics, lifestyle, and environment can influence the development and progression of obesity. Managing weight through diet, exercise, and lifestyle changes is crucial to addressing this condition.