Biohaven Ltd. (NYSE:BHVN) shares gained about 2% on Thursday after the company announced that enrollment has been completed in its Phase 2 clinical trial evaluating taldefgrobep alfa as a potential treatment for obesity. Topline results from the study are expected in the second half of 2026.
The randomized, double-blind, placebo-controlled trial is testing both once-weekly and once-monthly dosing of taldefgrobep as a standalone therapy in adults who are overweight or obese. The study aims to enroll approximately 150 participants and includes a 24-week double-blind treatment phase followed by a 24-week open-label extension period.
Taldefgrobep is designed to inhibit the myostatin-activin signaling pathway, a mechanism that targets both fat and muscle tissue. The primary endpoint of the trial measures the percentage change in total body weight from baseline to Week 24. Secondary endpoints include changes in total body fat mass and lean body mass.
Earlier clinical research showed that taldefgrobep reduced fat mass while increasing lean muscle mass in healthy volunteers and other non-obese groups. In a Phase 1 trial, participants receiving the drug experienced reductions in total body fat mass of more than 6%, alongside increases in lean muscle mass of up to 4% after 29 days of treatment.
According to Biohaven, taldefgrobep has been tested in more than 700 participants across clinical trials and has demonstrated a favorable safety profile, with low rates of serious adverse events or treatment discontinuations.
Preclinical studies using obese mouse models also indicated that the drug, both as a monotherapy and in combination with a GLP-1 agonist, reduced fat mass and body weight while increasing lean muscle mass.
The current Phase 2 study is being conducted at 20 clinical research sites across the United States.