Dose Range Finding Study of Bimagrumab in Sarcopenia

Phase 2 Completed 217 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to determine the efficacy of repeat dosing with multiple dose levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older adults with sarcopenia. In addition, this study generated data on the safety, tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.

Timeline

Start: 2014-12-09
Primary completion: 2018-06-26
Completion: 2018-06-28

Outcome

Missed primary endpoint

registry analysis (superiority test); BYM338 700 mg vs Placebo; p = 0.134; Mean Difference (Final Values) 0.31 (95% CI -0.24 to 0.87); Mixed Models Analysis NCT02333331 ↗

paper CONCLUSIONS AND RELEVANCE: This randomized clinical trial found no significant difference between participants treated with bimagrumab vs placebo PMID 33074327 ↗

Publications

Rooks D, Swan T, Goswami B, Filosa LA, Bunte O, Panchaud N, Coleman LA, Miller RR, Garcia Garayoa E, Praestgaard J, Perry RG, Recknor C, Fogarty CM, Arai H, Chen LK, Hashimoto J, Chung YS, Vissing J, Laurent D, Petricoul O, Hemsley S, Lach-Trifilieff E, Papanicolaou DA, Roubenoff R. Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020836. doi: 10.1001/jamanetworkopen.2020.20836.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bimagrumab	Monoclonal antibody	70 mg	Intravenous
Subject	Bimagrumab	Monoclonal antibody	210 mg	Intravenous
Subject	Bimagrumab	Monoclonal antibody	700 mg	Intravenous