• Daniel Rooks, Therese Swan, Budhaditya Goswami, Lee Anne Filosa, Ola Bunte, Nicolas Panchaud, Laura A Coleman, Ram R Miller, Elisa Garcia Garayoa, Jens Praestgaard, Robert G Perry, Chris Recknor, Charles M Fogarty, Hidenori Arai, Liang-Kung Chen, Jun Hashimoto, Yoon-Sok Chung, John Vissing, Didier Laurent, Olivier Petricoul, Sarah Hemsley, Estelle Lach-Trifilieff, Dimitris A Papanicolaou, and Ronenn Roubenoff.
• Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts.
• JAMA Netw Open. 2020 Oct 1; 3 (10): e2020836.

ImportanceThe potential benefit of novel skeletal muscle anabolic agents to improve physical function in people with sarcopenia and other muscle wasting diseases is unknown.ObjectiveTo confirm the safety and efficacy of bimagrumab plus the new standard of care on skeletal muscle mass, strength, and physical function compared with standard of care alone in community-dwelling older adults with sarcopenia.Design, Setting, And ParticipantsThis double-blind, placebo-controlled, randomized clinical trial was conducted at 38 sites in 13 countries among community-dwelling men and women aged 70 years and older meeting gait speed and skeletal muscle criteria for sarcopenia. The study was conducted from December 2014 to June 2018, and analyses were conducted from August to November 2018.InterventionsBimagrumab 700 mg or placebo monthly for 6 months with adequate diet and home-based exercise.Main Outcomes And MeasuresThe primary outcome was the change in Short Physical Performance Battery (SPPB) score after 24 weeks of treatment. Secondary outcomes included 6-minute walk distance, usual gait speed, handgrip strength, lean body mass, fat body mass, and standard safety parameters.ResultsA total of 180 participants were recruited, with 113 randomized to bimagrumab and 67 randomized to placebo. Among these, 159 participants (88.3%; mean [SD] age, 79.1 [5.3] years; 109 [60.6%] women) completed the study. The mean SPPB score increased by a mean of 1.34 (95% CI, 0.90 to 1.77) with bimagrumab vs 1.03 (95% CI, 0.53 to 1.52) with placebo (P = .13); 6-minute walk distance increased by a mean of 24.60 (95% CI, 7.65 to 41.56) m with bimagrumab vs 14.30 (95% CI, -4.64 to 33.23) m with placebo (P = .16); and gait speed increased by a mean of 0.14 (95% CI, 0.09 to 0.18) m/s with bimagrumab vs 0.11 (95% CI, 0.05 to 0.16) m/s with placebo (P = .16). Bimagrumab was safe and well-tolerated and increased lean body mass by 7% (95% CI, 6% to 8%) vs 1% (95% CI, 0% to 2%) with placebo, resulting in difference of 6% (95% CI, 4% to 7%) (P < .001).Conclusions And RelevanceThis randomized clinical trial found no significant difference between participants treated with bimagrumab vs placebo among older adults with sarcopenia who had 6 months of adequate nutrition and light exercise, with physical function improving in both groups. Bimagrumab treatment was safe, well-tolerated, increased lean body mass, and decreased fat body mass. The effects of sarcopenia, an increasing cause of disability in older adults, can be reduced with proper diet and exercise.Trial RegistrationClinicalTrials.gov Identifier: NCT02333331; EudraCT number: 2014-003482-25.

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