Visugromab in Cachexia International Trial (“VINCIT”)
Research type
Research Study
Full title
Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab versus Placebo in Patients with Cancer associated Cachexia
IRAS ID
1013034
Contact name
Sujata Rao
Contact email
Sponsor organisation
CatalYm GmbH
Clinicaltrials.gov Identifier
Research summary
Cancer-associated cachexia is a syndrome that is very common in late-stage of advanced cancer. It is marked by weight loss, feeling sick, loss of appetite, loss of muscle and fat and a reduced ability to carry out daily tasks.
The purpose of this trial is to learn about how well and safely visugromab works when used to treat cancer-associated cachexia. Visugromab works by blocking the GDF-15 protein believed to cause some cachexia symptoms.
This trial is split into 2 parts. Part 1 will involve approximately 180 participants and Part 2 will involve approximately a further 350 participants.
Part 1 will compare different doses of visugromab to a placebo (inactive substance) to find out which dose of visugromab works the best.
Part 2 will use this most effective dose from Part 1 to see how safe and effective visugromab is compared to a placebo.
Participants in this trial will receive either visugromab or placebo in addition to the standard anticancer treatment prescribed by their doctors. This is a double-blind study trial, meaning neither participants nor the trial doctors and nurses will know which treatment is being received. The participants will have a 75% chance of receiving a dose of visugromab in Part 1 and 66% chance in Part 2.
In Part 1 participants will receive the trial treatment 3 times during a 12-week period, with a total participation in the trial being a maximum of 28 weeks.
In Part 2 participants will receive the trial treatment 137 times during a 48-week period, a total participation in the trial being a maximum of 56 weeks.
In ongoing clinical trials the following adverse events have been reported: fever, blood clots in artery of the lung, diarrhea, and liver inflammation. Participants will be monitored for any potential side effects.
Participants may or may not benefit from their participation in this trial. The information collected may help patients with the same disease get better care in the future.REC name
Wales REC 3
REC reference
26/WA/0008
Date of REC Opinion
17 Feb 2026
REC opinion
Further Information Favourable Opinion