Cancer-associated Cachexia
Conditions
Keywords
Cachexia, Cancer, Weight loss, Wasting, Anorexia
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.
Interventions
High dose
DRUGPlacebo
IV infusion
Sponsors
CatalYm GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Functional Assessment of Anorexia/Cachexia Therapy instrument (minimum score 0, maximum 20; higher is better outcome) |
Countries
Bulgaria, Czechia, France, Germany, Italy, Norway, Poland, Romania, Spain, Switzerland, United Kingdom, United States
Contacts
CONTACTTrial Director
Outcome results
None listed