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BELIEVE study assessing bimagrumab for obesity completes enrolment

The BELIEVE global Phase 2b study - assessing bimagrumab as a single agent and in combination with semaglutide in patients with obesity - has completed enrolment, with 507 patients randomised. The primary phase of the study will assess the safety and efficacy of bimagrumab as a monotherapy and in combination with semaglutide over 48 weeks of treatment. The study seeks to demonstrate that co-administration of bimagrumab has the potential to substantially prevent the loss of muscle mass observed with semaglutide and other incretin therapies.

Bimagrumab is a first-in-class monoclonal antibody that binds activin type II A and B receptors. A prior Phase 2a study assessing bimagrumab in patients with obesity and type 2 diabetes showed a 21.9% reduction in fat mass after 48 weeks of therapy while increasing lean muscle mass by 4.5%.

In the same study, patients were followed for an additional 12 weeks after the last dose of bimagrumab and experienced no weight regain. In contrast, rapid weight regain has been observed in patients who stop taking semaglutide and other incretins.

In preclinical experiments, coadministration of bimagrumab with incretins had an additive effect on total fat loss while preserving muscle mass. The study will continue through a second phase, with patients remaining on treatment through 72 weeks, followed by an off-treatment period to evaluate weight loss maintenance through 104 weeks.

"While the new generation of incretin therapies have been revolutionary for patients living with obesity, bimagrumab addresses a critical unmet need as a therapeutic that targets fat loss while building muscle mass," said Dr Mark Pruzanski, CEO of Versanis. "This enables patients to achieve the best weight loss quality, which we anticipate will lead to optimal metabolic health and sustained long-term benefit."


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