Visugromab in Cachexia International Trial
ConditionCancer-associated Cachexia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCatalYm GmbH
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Weight loss
Advanced cancer
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Visugromab (CTL-002)
DrugHigh dose
Placebo
DrugIV infusion
Visugromab (CTL-002)
DrugMedium dose
Visugromab (CTL-002)
DrugLow dose
Treatment groups
518 Participants
are divided into 4 treatment groupsGroup A: Visugromab low doseActive comparator 1 intervention
Group B: Visugromab medium doseActive comparator 1 intervention
Group C: Visugromab high doseActive comparator 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in body weight at 12 weeks
Time frame
12 weeks2
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov