Visugromab in Cachexia International Trial
- Conditions
- Cancer-associated Cachexia
- Interventions
- Drug: Visugromab (CTL-002)Drug: Placebo
- Registration Number
- NCT07112196
- Lead Sponsor
- CatalYm GmbH
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 518
- Weight loss
- Advanced cancer
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Visugromab low dose Visugromab (CTL-002) - Visugromab medium dose Visugromab (CTL-002) - Visugromab high dose Visugromab (CTL-002) - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline in body weight at 12 weeks 12 weeks Change from baseline in appetite at 12 weeks 12 weeks Measured on the 5-item anorexia subscale of the FAACT instrument
- Secondary Outcome Measures
Name Time Method