Biohaven Completes Enrollment in Phase 2 Obesity Trial; Data Due 2H 2026
Biohaven has fully enrolled approximately 150 participants across 20 US sites in its randomized, placebo-controlled Phase 2 obesity study testing once-weekly and once-monthly taldefgrobep alfa. Topline data on percent change in body weight, fat mass and lean mass are expected in 2H 2026.
1. Enrollment Milestone
Biohaven has finalized enrollment of approximately 150 adults with overweight or obesity across 20 clinical sites in the US for its Phase 2 proof-of-concept trial of taldefgrobep alfa. The study includes both once-weekly and once-monthly dosing via self-administered autoinjector.
2. Study Design and Endpoints
The randomized, double-blind, placebo-controlled study features a 24-week treatment period followed by a 24-week open-label extension and will measure percent change in total body weight as the primary endpoint, with secondary endpoints including total body fat and lean mass changes.
3. Mechanism and Prior Clinical Data
Taldefgrobep alfa is a novel myostatin-activin pathway inhibitor designed to reduce fat mass while increasing lean muscle. Previous trials in non-obese adults demonstrated over 6% fat mass reduction and up to 4% lean mass gain, with a favorable safety profile in more than 700 participants.
4. Next Steps and Implications
Topline results are expected in the second half of 2026 and could validate a new obesity treatment modality that complements GLP-1 agonists by preserving muscle mass. Positive data may bolster Biohaven’s clinical-stage pipeline valuation and strategic positioning in obesity therapeutics.