Bimagrumab for treatment of sarcopenia in community-dwelling older adults: a phase II, randomized, controlled trial
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Background: The potential benefit of novel skeletal muscle anabolic agents to improve physical function in people with sarcopenia and other muscle wasting diseases is unknown. \nObjective: To confirm the safety and efficacy of bimagrumab on skeletal muscle mass, strength, and physical function in community-dwelling older adults with sarcopenia. \nDesign: Randomized, double-blind, placebo-controlled. \nSetting: 38 sites in 13 countries. \nParticipants: 180 community-dwelling, men and women aged ≥70 years meeting gait speed and skeletal muscle criteria for sarcopenia. \nIntervention: Bimagrumab 700 mg (n=113) or placebo (n=67) monthly for 6-months with appropriate diet and home-based exercise. \nMeasurements: Short Physical Performance Battery (SPPB), 6-minute walk distance (6MWD), gait speed, handgrip strength, total lean body mass (LBM), and standard safety parameters. \nResults: 159/180 (88.3%) participants (mean age: 79.1 years; 60.6% women) completed the study. Bimagrumab was safe, well-tolerated and increased LBM by 6.0% over placebo (P<0.001). The mean SPPB score increased by 1.34 (0.90–1.77, mean, 95%CI) with bimagrumab versus 1.03 (0.53–1.52) with placebo (P=0.134); 6MWD increased by 24.60 m (7.65–41.56 m) versus 14.30 m (−4.64–33.23 m; P=0.163); and gait speed increased by 0.14 m/s (0.09–0.18 m/s) versus 0.11 m/s (0.05–0.16 m/s; P=0.161). Handgrip strength did not change. \nLimitation: Powered only for key functional endpoints. \nConclusion: Bimagrumab treatment over 6-months was safe, well-tolerated and increased LBM in community-dwelling older adults with sarcopenia. Appropriate nutrition and exercise improved physical performance in this vulnerable population; bimagrumab did not significantly enhance this effect. At the completion of the study, a majority of participants in both treatment groups no longer met sarcopenia criteria. Sarcopenia, an increasing cause of disability in the elderly, is reversible with proper diet and exercise. \nClinicalTrials.gov identifier: NCT02333331 \nKeywords: bimagrumab; sarcopenia; muscle; lean body mass; SPPB; gait speed; \n6-minute walk test \n
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