Caliway Biopharmaceuticals reported positive Phase 2b trial results for its experimental fat-reduction drug CBL-514, setting the stage for broader testing of what could become the first non-surgical treatment for localized fat deposits.
The Taiwan-based biotech company conducted trials in the US and Australia, enrolling 107 patients with moderate to severe abdominal fat. The study showed that 76.7% of participants who received CBL-514 injections experienced significant improvement in fat reduction, compared to 18.9% in the placebo group.
The randomized, placebo-controlled trial administered up to four injections over a 12-week period, with doses capped at 600 milligrams. Researchers used MRI scans and the Abdominal Fat Rating Scale to measure outcomes, following FDA-recommended protocols for future Phase 3 studies.
While the company claims the drug demonstrated strong safety and tolerability profiles, independent experts will need to verify these results in larger trials. Caliway Biopharmaceuticals plans to initiate global Phase 3 trials in 2025, though regulatory hurdles remain before any potential commercialization.
The market for non-surgical fat reduction treatments continues to grow, with several companies competing to develop effective alternatives to liposuction and other invasive procedures.