Not recruiting

Study on the Effects of RO7204239 and Tirzepatide for Weight Loss in Patients with Obesity or Overweight with a Weight-Related Health Issue

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 new drug combination for individuals with obesity or those who are overweight and have at least one related health issue, such as high blood pressure or sleep apnea. The study will test a combination of two treatments: RO7204239, a humanized antibody designed to target a protein called latent myostatin, and tirzepatide, a medication that helps lower blood sugar levels. The purpose of the study is to assess how effective this combination is in helping participants lose weight over a period of 48 weeks.

Participants in the study will receive either the combination of RO7204239 and tirzepatide or a placebo with tirzepatide. The study will last for 48 weeks, during which participants will receive regular injections under the skin. Throughout the study, various health measurements will be taken to monitor changes in body weight, body mass index (BMI), and other health markers. These measurements will help determine the safety and effectiveness of the treatment.

The trial aims to provide valuable insights into how this new drug combination can aid in weight loss while maintaining muscle mass. By comparing the results of those receiving the active treatment with those receiving the placebo, researchers hope to better understand the potential benefits and any side effects of the treatment. The study is expected to conclude by the end of 2027.

The research process

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

Step 1
Joining the trial
Upon joining the trial, you will be randomly assigned to receive either the new drug combination or a placebo. This process is called randomization and ensures that the study results are unbiased.
Step 2
Medication administration
You will receive a medication called tirzepatide through a subcutaneous injection, which means it is injected under the skin. The dosage may vary, including options such as 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per dose.
The injections will be administered using a pre-filled pen known as a KwikPen. The frequency of these injections will be determined by the study protocol.
Step 3
Treatment duration
The treatment will last for a total of 48 weeks. During this time, you will continue to receive the assigned medication or placebo as per the study schedule.
Step 4
Regular assessments
Throughout the trial, you will undergo regular assessments to monitor your health and the effects of the treatment. These assessments may include measurements of body weight, body mass index (BMI), and other health indicators.
You may also have imaging tests such as dual-energy x-ray absorptiometry (DXA) and magnetic resonance imaging (MRI) to evaluate changes in body composition and muscle volume.
Step 5
End of trial
At the end of the 48-week period, your participation in the trial will conclude. Final assessments will be conducted to gather data on the effects of the treatment.
The primary goal is to assess the percentage change in body weight from the start of the trial to the end of the 48 weeks.

Who can join the trial?

7 criteria

Able and willing to provide written consent to participate in the study and follow the study rules.
Men or women who are 18 years or older.
Have a Body Mass Index (BMI) between 27.0 and 30.0. BMI is a measure of body fat based on height and weight.
Have at least one weight-related health issue, such as high blood pressure, abnormal cholesterol levels, sleep apnea, or heart disease.
Have tried at least once to lose weight through diet or exercise but were not successful.
Have maintained a stable weight, with less than a 5 kg (11 lbs) change, in the last 3 months before the study starts.
Agree to follow the study's rules about using birth control.

Who cannot join the trial?

3 criteria

Patients who are not within the specified age range cannot participate.
Patients who are not diagnosed with obesity cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

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.
Verified
Gdansk, Poland
Hospital Clinico San Carlos
Verified
Madrid, Spain
Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

RO7204239
is a medication being studied to see if it can help people lose weight. It is being tested in combination with another medication to see if it can help people who are overweight or have obesity, especially if they have other health problems related to their weight. The goal is to find out if this medication can help people lose weight safely and effectively over a period of 48 weeks.
Tirzepatide
is a medication that is already known to help with weight loss. In this trial, it is being used together with another medication to see if the combination can help people lose more weight than using tirzepatide alone. The study aims to understand how well this combination works and if it is safe for people to use over a long period of time.

What is already known about the treatment

RO7204239 – RO7204239 is administered in combination with another medication called tirzepatide, and it is taken by participants in a clinical trial setting. This medication is currently being studied in a Phase 2 clinical trial to evaluate its effectiveness, safety, and tolerability for individuals who are obese or overweight and have at least one weight-related health issue. The main goal of this trial is to see how well RO7204239, when used with tirzepatide, helps with weight loss over a period of 48 weeks. The exact way RO7204239 works at the molecular level is still under investigation, but it is being explored for its potential to aid in weight management.

Investigated diseases

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It develops when there is an imbalance between calories consumed and calories expended, leading to weight gain. Over time, this excess weight can lead to increased fat tissue, particularly around the waist and other areas. As obesity progresses, it can affect the body's metabolism and increase the risk of developing other health issues. The condition can also lead to changes in body composition, such as increased fat mass and altered muscle mass. Obesity is often associated with changes in glucose metabolism and lipid profiles.