RecruitingPHASE2, PHASE3INTERVENTIONAL

Visugromab in Cachexia International Trial

This study is testing a new drug called visugromab for people who have cancer, including lung and bowel cancer, and are experiencing severe weight loss, known as cachexia. Cachexia can make people very weak and tired. The main aims are to see if visugromab can help people put weight back on, improve their appetite, and help them move around more easily. Researchers will also carefully watch for any side effects the new drug might cause. Participants will either receive visugromab or a placebo (a 'dummy' treatment with no active medicine) through a drip. They will have regular check-ups at a hospital or clinic every four weeks to monitor their progress and safety.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

CatalYm GmbH

Enrolment target

518

Start

16 Apr 2026

Estimated completion

01 Dec 2030

Cancer-associated Cachexia

What is this study about?

This study is investigating a new medication called visugromab. It's designed for people who are living with certain types of cancer, like lung cancer or bowel cancer, and are also experiencing a condition called cachexia. Cachexia is a serious problem where people lose a lot of weight, especially muscle, and can feel very weak and tired, even if they are eating. It's a common and difficult part of having cancer, and at the moment, there aren't many good treatments for it.

The main aim of this research is to find out if visugromab can help people with cancer-related cachexia. The study hopes to answer several important questions: Can this drug help people gain weight and feel hungrier? Does it make it easier for them to move and be more active? The researchers will also pay close attention to any possible side effects or other medical issues that might occur while people are taking visugromab.

To understand how well visugromab works, some participants will receive the active drug, while others will receive a placebo. A placebo looks exactly like the real drug but contains no active medicine. This comparison helps researchers to be sure that any changes they see are truly due to the drug and not just other factors. By taking part, people could potentially help future patients manage cachexia better.

Key takeaways

A new drug called visugromab is being tested for cancer-related weight loss (cachexia).
The study aims to see if it helps with weight gain, appetite, and movement.
Participation involves regular hospital visits for treatment and check-ups.
Some people will receive the new drug, while others will get a placebo.
This research hopes to find better ways to help people living with cancer and cachexia.

Who may be eligible?

To be part of this study, you would need to meet certain requirements. The main ones are that you are an adult, aged 18 or older, and you have experienced unexplained weight loss. You also need to have advanced cancer.

There are some reasons why you might not be able to join. For example, if you are already taking part in another medical study that involves trying out a new treatment or device, you would not be eligible. This is important because being in more than one study at a time could make it harder for researchers to understand what effects each treatment is having. You also cannot have received any other experimental treatments within four weeks before this study starts.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you experienced unexplained weight loss?
Do you have advanced cancer?
Are you NOT currently taking part in another clinical trial testing a new treatment or device?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would visit a hospital or clinic once every four weeks. During these visits, you would receive the study medication, either visugromab or a placebo, through a drip directly into a vein. These visits will also involve check-ups and various tests to monitor your health, how you're responding to the treatment, and to check for any side effects. These regular appointments are important to ensure your safety and to gather all the necessary information for the study. The total length of your participation would depend on the study design, but it involves ongoing visits every four weeks.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as the possibility that visugromab could help you gain weight, improve your appetite, and increase your ability to move, though there's no guarantee it will work for everyone. There are also potential risks, including side effects from the drug, which the medical team will carefully monitor. You will be told about all known risks before you start. Remember, joining a study is always your choice, and you are free to withdraw at any time without explaining why, and it won't affect your usual medical care.

Locations (34)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Clermont Oncology Center
Verified postcode
Clermont, United States· Not yet recruiting
Mid Florida Hematology and Oncology Centers
Verified postcode
Orange City, United States· Recruiting
Cleveland Clinic Avon Hospital
Verified postcode
Avon, United States· Not yet recruiting
Cleveland Clinic (Main Campus)
Verified postcode
Cleveland, United States· Not yet recruiting
Cleveland Clinic Fairview Hospital
Verified postcode
Fairview, United States· Not yet recruiting
Cleveland Clinic Hillcrest Hospital
Verified postcode
Mayfield Heights, United States· Not yet recruiting
Specialized Hospital for Active Treatment in Oncology
Verified postcode
Haskovo, Bulgaria· Recruiting
Medical Centre Futuremeds Plovdiv
Verified postcode
Plovdiv, Bulgaria· Not yet recruiting
Multiscan, s.r.o., Nemocnice Horovice
Verified postcode
Hořovice, Czechia· Not yet recruiting
Léon Bérard Center (Centre Léon Bérard)
Verified postcode
Lyon, France· Recruiting
University Hospital Carl Gustav Carus Dresden (Universitätsklinikum Carl Gustav Carus Dresden)
Verified postcode
Dresden, Germany· Recruiting
ASST degli Spedali Civili di Brescia
Verified postcode
Brescia, Italy· Recruiting

Common questions

What is cachexia?

Cachexia is severe weight loss, especially of muscle, often linked to serious illnesses like cancer, making people feel very weak.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real drug but contains no active medicine. It helps researchers compare effects.

How will I receive the study drug?

You will receive the study drug through a drip into a vein at the hospital or clinic, typically once every four weeks.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your medical care.

What cancers are included in this study?

The study includes people with certain types of cancer that cause cachexia, such as lung cancer and bowel cancer.

How to find out more

Trial Director

regulatory-006@catalym.com 49 8920006640 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.