Study of Safety, Tolerability, and Pharmacokinetics of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men

Phase 1 Completed 82 enrolled Regeneron Pharmaceuticals

RandomizedParallel-groupQuadruple-blindBasic science

Summary

The primary objective is to assess the safety and tolerability of REGN2477 alone and combined with REGN1033. The secondary objectives are to: * Assess the effect of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on thigh muscle volume * Assess the effects of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on total and regional body composition * Evaluate the Pharmacokinetic (PK) profile of REGN2477 and REGN1033 * Assess immunogenicity of REGN2477 or REGN1033 * Assess REGN2477 or REGN1033 target engagement

Timeline

Start: 2016-12-08
Primary completion: 2019-04-30
Completion: 2019-04-30

Publications

Gonzalez Trotter D, Donahue S, Wynne C, Ali S, Parasoglou P, Boyapati A, Mohammadi K, Musser BJ, Meier P, Mastaitis J, Sleeman MW, Glass DJ, Gasparino E, Trejos J, Davis JD, Hirshberg B, Pordy R, Yancopoulos GD, Herman GA. GDF8 and activin A are the key negative regulators of muscle mass in postmenopausal females: a randomized phase I trial. Nat Commun. 2025 May 13;16(1):4376. doi: 10.1038/s41467-025-59380-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Garetosmab	Monoclonal antibody	—	—
Subject	Trevogrumab	Monoclonal antibody	—	—

Indications

No indication recorded.