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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.	Lodz	Poland
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Area Sanitaria De Ferrol	Ferrol	Spain
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.	Wroclaw	Poland
Instituto Medico Quirurgico San Rafael S.A.	A Coruna Galicia	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Elhhvt Szn z olwz	Lublin	Poland
Hwtwawap Uzzgwhquonqur Mujmomy Ds Vzvsiifgsy	Santander	Spain
Caznlaf Bsyzg Keqtsdzogps Pbgidrbi Snz z oqwo	Gdansk	Poland
Hxazwtcc Vawr dnoivuzs	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	01.07.2025
Spain	Not recruiting	01.07.2025

Trial locations

Investigated drugs:

Tirzepatide

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.

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.

Trial ID:

2024-519561-22-00

Protocol code:

BC45538

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?