NCT07112196

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 518 (estimated)
• Sponsor: CatalYm GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer-associated Cachexia

Interventions

Type	Name	Description
DRUG	Visugromab (CTL-002)	High dose
DRUG	Placebo	IV infusion
DRUG	Visugromab (CTL-002)	Medium dose
DRUG	Visugromab (CTL-002)	Low dose

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-12-01
• Completion: 2030-12-01
• First posted: 2025-08-08
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study