Visugromab in Cachexia International Trial

A study of how well and safely a new drug called visugromab works in people with certain kinds of cancer (including lung and bowel cancer) and unintended weight loss known as cachexia. The main questions it aims to answer are:

* Does visugromab help participants put weight back on and have a better appetite? * Does visugromab help participants move more and better? * What medical problems do participants have when taking visugromab? Researchers will compare visugromab to a placebo (a look-alike substance that contains no drug).

Participants will visit the hospital or clinic once every 4 weeks to receive visugromab or placebo via a drip into a vein and to undergo checkups and tests.

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Key information

Conditions

Cancer-associated Cachexia Anorexia Body Weight Body Weight Changes Cachexia Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Thinness Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Specialized Hospital for Active Treatment in Oncology, Haskovo, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Weight loss
Advanced cancer

Exclusion criteria

Participation in another interventional clinical trial, receipt of any investigational therapy or use of any investigational device within 4 weeks prior to screening and between screening and the first dose of investigational product

Treatment and study plan

Visugromab (CTL-002)

Drug

High dose

Placebo

Drug

IV infusion

Primary outcomes

Change from baseline in body weight at 12 weeks

Time frame: 12 weeks
Change from baseline in appetite at 12 weeks

Time frame: 12 weeks

Measured on the 5-item anorexia subscale of the Functional Assessment of Anorexia/Cachexia Therapy instrument (minimum score 0, maximum 20; higher is better outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Director

CONTACT

[email protected]

49 8920006640

Sponsors and collaborators

Lead sponsor

CatalYm GmbH

Industry

Registry information

Official study title

Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo in Patients With Cancer-associated Cachexia

Acronym: VINCIT

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2030
First posted: Aug 8, 2025
Registry last updated: Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting