Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese

Phase 2 Completed 102 enrolled Scholar Rock, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A phase 2 study to evaluate the effects of apitegromab as an adjunctive therapy to GLP-1 receptor agonist therapy in subjects with overweight or obesity

Timeline

Start: 2024-05-21
Primary completion: 2025-03-04
Completion: 2025-06-17

Outcome

Met primary endpoint

paper 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) PMID 42260100 ↗

Publications

Pratley RE, Denham DS, Trivedi R, Watkins E, Connery L, Barnes J, Yu D, Hong J, Simard C, Umans K, Liu L, Tirucherai GS, Marantz JL. Apitegromab for lean mass preservation during tirzepatide-induced weight loss: a randomized, double-blind, placebo-controlled phase 2 trial. Nat Med. 2026 Jun 8. doi: 10.1038/s41591-026-04440-4. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apitegromab	Monoclonal antibody	10 mg/kg	Intravenous
Background	Tirzepatide	Peptide	—	Subcutaneous

Indications

No indication recorded.