Apitegromab
Between-group difference: 1.9 kg less lean-mass loss (80% CI 1.2–2.7), with similar weight loss.
Evidence in context
Completer analysis, descriptive statistics and no multiplicity adjustment limit certainty. Less lean loss is not muscle gain or demonstrated functional improvement.
Study details
Doses studied — not a dosing recommendation. Regimens belong to the named study, formulation and population.
EMBRAZE randomized phase 2 trial
- Population
- 102 randomized adults; primary analysis included 87 completers with week-24 DXA.
- Doses and administration studied
- Apitegromab 10 mg/kg intravenously every four weeks plus weekly subcutaneous tirzepatide, escalated up to 15 mg, versus placebo plus tirzepatide.
- Duration
- 24 weeks
- Reported finding / status
- Between-group difference: 1.9 kg less lean-mass loss (80% CI 1.2–2.7), with similar weight loss.
- Interpretation and limitations
- Completer analysis, descriptive statistics and no multiplicity adjustment limit certainty. Less lean loss is not muscle gain or demonstrated functional improvement.
Source tier B · Read the original study or record
Outcome Evidence Strength
Published phase 2 measurements support a lean-preservation signal, not added weight-loss efficacy or proven function.
Approval is indication-specific
Scholar Rock announced U.S. approval of ISEMBYLD for a defined SMA population on September 11, 2026. That is separate from the investigational obesity combination summarized here. The obesity M3 and 3/3/3/0 outcome snapshot remain scoped to EMBRAZE, without importing SMA function results.