Scholar Rock announced positive results from its Phase 2 EMBRAZE proof-of-concept trial, demonstrating statistically significant preservation of lean mass with apitegromab when combined with tirzepatide. The trial assessed apitegromab's ability to mitigate lean mass loss during tirzepatide-induced weight loss in individuals with obesity or overweight.
Apitegromab therapy (10 mg/kg) with tirzepatide preserved an additional 4.2 pounds (1.9 kg), or 54.9% (p=0.001), of lean mass compared to tirzepatide alone over 24 weeks. This resulted in a 'higher quality of weight loss,' halving the proportion of lean mass lost to 14.6% compared to 30% with tirzepatide alone.
The combination of apitegromab with tirzepatide was generally well tolerated, with no serious adverse events or discontinuations related to apitegromab treatment. These results provide clinical validation for Scholar Rock's myostatin inhibition approach in cardiometabolic disorders, and the company remains on track to file an IND application for SRK-439 in the second half of 2025.
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