RecruitingPhase 2Phase 3NCT07112196

Visugromab in Cachexia International Trial

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


Sponsor

CatalYm GmbH

Enrollment

518 participants

Start Date

Apr 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Weight loss
  • Advanced cancer

Exclusion Criteria1

  • 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

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Interventions

DRUGVisugromab (CTL-002)

High dose

DRUGPlacebo

IV infusion

DRUGVisugromab (CTL-002)

Medium dose

DRUGVisugromab (CTL-002)

Low dose


Locations(7)

Mid Florida Hematology and Oncology Centers

Orange City, Florida, United States

Specialized Hospital for Active Treatment in Oncology

Haskovo, Bulgaria

Léon Bérard Center (Centre Léon Bérard)

Lyon, France

Oslo University Hospital

Oslo, Norway

University Hospital of A Coruña (Hospital Universitario de A Coruña)

A Coruña, Spain

Cantonal Hospital St. Gallen (Kantonsspital St. Gallen)

Sankt Gallen, Switzerland

University Hospital of Zurich (Universitätsspital Zürich)

Zurich, Switzerland

View Full Details on ClinicalTrials.gov

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NCT07112196