The U.S. Food and Drug Administration (FDA) has approved ISEMBYLD (apitegromab-mstn) for adults and children two years of age and older with Spinal Muscular Atrophy (SMA) who are currently receiving o

In the phase 2 EMBRAZE study, participants receiving tirzepatide and apitegromab lost less lean mass compared to participants receiving tirzepatide and placebo.

A drug called apitegromab may help to preserve lean body mass during weight loss with tirzepatide, a GLP-1 receptor agonist, according to a phase 2 clinical trial published in Nature Medicine.

Loss of lean mass in proportion to total weight loss is observed with incretin mimetic therapies such as tirzepatide and has the potential to adversely affect health and function. Apitegromab is an investigational, fully human monoclonal antibody that selectively inhibits myostatin activation and is, thereby, capable of increasing muscle mass. In the randomized, double-blind, placebo-controlled phase 2 EMBRAZE study, adults with overweight or obesity (n = 102) were randomized 1:1 to receive tirzepatide plus apitegromab (10 mg kg−1) or tirzepatide plus placebo. At week 24, apitegromab resulted in a least square mean (80% confidence interval (CI)) of 1.9 (1.2−2.7) kg less lean mass loss than placebo (P = 0.001), despite similar total body weight loss between groups, representing a 54.9% retention of lean mass relative to placebo. In participants receiving apitegromab, trough concentrations of apitegromab and total latent myostatin, a pharmacodynamic marker, both increased over time and r

Motor function may improve with adjunctive apitegromab

In the phase 2 EMBRAZE study, participants receiving tirzepatide and apitegromab lost less lean mass compared to participants receiving tirzepatide and placebo.

CAMBRIDGE, Mass., September 11, 2026--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular dis...

In the phase 2 EMBRAZE study, participants receiving tirzepatide and apitegromab lost less lean mass compared to participants receiving tirzepatide and placebo.

A study finds combining apitegromab with tirzepatide may help preserve lean muscle while supporting weight loss in people with obesity.

La Agencia del medicamento y producto sanitario de EE.UU. (FDA) ha rechazado la aprobación de la terapia muscular apitegromab de Scholar Rock

A phase 2 trial found that apitegromab plus tirzepatide reduced lean body mass loss by 1.9 kg compared with tirzepatide plus placebo after 24 weeks, while overall weight loss remained similar.

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FDA approves Scholar Rock's Isembyld (apitegromab) for SMA after Indiana manufacturing hurdles; shares jump 10% premarket.

A drug called apitegromab may help preserve lean body mass during weight loss with tirzepatide, a GLP-1 receptor agonist, according to a phase 2 clinical trial published in Nature Medicine.