Apitegromab for lean mass preservation during tirzepatide-induced weight loss: a randomized, double-blind, placebo-controlled phase 2 trial
Primary result · Lean mass lossResult — go to the resultLeast square mean difference (less lean mass loss) 1.9 kg 80% CI 1.2–2.7Authors' conclusion
In summary, this proof-of-concept study demonstrated that selective targeting of myostatin by apitegromab was well tolerated and effective in preserving lean mass when combined with tirzepatide.
Study context
- Population
- Adults with overweight or obesity receiving tirzepatiderandomized 1:1
- Participants
- 102 adults
- Comparison
- Tirzepatide plus apitegromab vs tirzepatide plus placebo
- Apitegromabn = 51
- Placebon = 51reference
- Primary endpoint
- Lean mass loss
- Follow-up
- Week 24
Methodological detailsdouble-blind, placebo-controlled, phase 2, proof-of-concept
- Double-blind
- Placebo-controlled
- Phase 2
- Proof-of-concept
Primary result
As reported in the abstract
Least square mean difference (less lean mass loss)
1.9 kg
80% CI 1.2–2.7
P = 0.001
Apitegromabvs Placebo
least square mean difference (less lean mass loss) 1.9 kg (80% CI 1.2–2.7); P = 0.001
- Retention of lean mass relative to placebo
- 54.9%
Further findings
Trough apitegromab and total latent myostatin (pharmacodynamic marker), apitegromab recipients
- Both increased over time and reached a plateau after ≈16 weeks
Safety
| Outcome | Apitegromab | Placebo |
|---|---|---|
| Adverse events | 76% (95% CI 63–86%) | 71% (95% CI 57–81%) |
| Serious adverse events | 2% (95% CI 0–10%) | 2% (95% CI 0–10%) |
Adverse events
- Incidence generally similar across groups
Serious adverse events
- Serious adverse events (SAEs) balanced
Original publication
Apitegromab for lean mass preservation during tirzepatide-induced weight loss: a randomized, double-blind, placebo-controlled phase 2 trial. Nat Med. Published 8 June 2026. doi:10.
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