RecruitingInterventionalPhase 2/Phase 3

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

NCT ID: NCT07112196Sponsor: CatalYm GmbHLast updated: 2026-06-09

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.

Arms & interventions

DrugVisugromab (CTL-002)
High dose
DrugPlacebo
IV infusion
DrugVisugromab (CTL-002)
Medium dose
DrugVisugromab (CTL-002)
Low dose

Outcome measures

Primary

Change from baseline in body weight at 12 weeks
Time frame: 12 weeks
Change from baseline in appetite at 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)
Time frame: 12 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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

Study locations (6)

Clermont Oncology Center

Clermont, Florida, 34711

Not Yet Recruiting

Mid Florida Hematology and Oncology Centers

Orange City, Florida, 32763

Recruiting

Cleveland Clinic Avon Hospital

Avon, Ohio, 44011

Not Yet Recruiting

Cleveland Clinic (Main Campus)

Cleveland, Ohio, 44195

Not Yet Recruiting

Cleveland Clinic Fairview Hospital

Fairview, Ohio, 44111

Not Yet Recruiting

Cleveland Clinic Hillcrest Hospital

Mayfield Heights, Ohio, 44124

Not Yet Recruiting