Clinical-stage biopharmaceutical company Versanis Bio has begun enrolment at sites in the US, Australia, and New Zealand for the BELIEVE Phase IIb study to evaluate the safety and efficacy of bimagrumab alone, as well as in combination with semaglutide, to treat obesity.
A first-in-class, completely human, monoclonal antibody, bimagrumab targets activin type II receptors.
It is claimed to be the only candidate in clinical development to treat obesity that drives huge fat loss while also boosting muscle mass.
BELIEVE is a placebo-controlled, 48-week, randomised Phase IIb trial, with a target of enrolling 450 non-diabetic patients who are overweight or suffer from obesity problems. The participants in the trial will receive a placebo or bimagrumab, with or without semaglutide.
The global trial will evaluate the safety and efficacy of bimagrumab as a monotherapy, as well as when co-administered with semaglutide.
Versanis Bio stated that approximately one third of the weight loss with semaglutide and other incretin therapies leads to reduced lean mass with related muscle loss.
Wide clinical safety and efficacy data for bimagrumab has been produced in over 20 previous studies, with its exposure in over 1,000 patients for up to 18 months.
This data also features a Phase II study spanning 48 weeks on patients with type 2 diabetes and overweight or obesity problems in whom bimagrumab generated a placebo-adjusted approximate 22% fat mass loss, along with a 4.5% lean mass gain, even though there was only minimal change in intake of calories.
Compared to the quick off-treatment rebound impact usually reported with incretin therapies, no weight regain was seen through 12 weeks, even after stopping the bimagrumab treatment.
Versanis chief medical officer Kenneth Attie said: “Initiation of the BELIEVE study is a significant milestone in our journey to advance bimagrumab as a potentially transformational new treatment for obesity that can produce significant fat loss, along with an increase in muscle mass, which provides better quality weight loss overall.
“We are thrilled with the enthusiasm for the study and have already enrolled close to 20% of our targeted patients.”