OBJECTIVES: To assess the effects of bimagrumab on skeletal muscle mass and function in older adults with sarcopenia and mobility limitations. DESIGN: A 24-week, randomized, double-blind, placebo-controlled, parallel-arm, proof-of-concept study. SETTING: Five centers in the United States. PARTICIPANTS: Community-dwelling adults (N = 40) aged 65 and older with gait speed between 0.4 and 1.0 m/s over 4 m and an appendicular skeletal muscle index of 7.25 kg/m2 or less for men and 5.67 kg/m2 or less for women. INTERVENTION: Intravenous bimagrumab 30 mg/kg (n = 19) or placebo (n = 21). MEASUREMENTS: Change from baseline in thigh muscle volume (TMV), subcutaneous and intermuscular fat, appendicular and total lean body mass, grip strength, gait speed, and 6-minute walk distance (6MWD). RESULTS: Thirty-two (80%) participants completed the study. TMV increased by Week 2, was sustained throughout the treatment period, and remained above baseline at the end of study in bimagrumab-treated participants, whereas there was no change with placebo treatment (Week 2: 5.15 ± 2.19% vs -0.34 ± 2.59%, P < .001; Week 4: 6.12 ± 2.56% vs 0.16 ± 3.42%, P < .001; Week 8: 8.01 ± 3.70% vs 0.35 ± 3.32%, P < .001; Week 16: 7.72 ± 5.31% vs 0.42 ± 5.14%, P < .001; Week 24: 4.80 ± 5.81% vs -1.01 ± 4.43%, P = .002). Participants with slower walking speed at baseline receiving bimagrumab had clinically meaningful and statistically significantly greater improvements in gait speed (mean 0.15 m/s, P = .009) and 6MWD (mean 82 m, P = .022) than those receiving placebo at Week 16. Adverse events in the bimagrumab group included muscle-related symptoms, acne, and diarrhea, most of which were mild in severity and resolved by the end of study. CONCLUSION: Treatment with bimagrumab over 16 weeks increased muscle mass and strength in older adults with sarcopenia and improved mobility in those with slow walking speed.
RCT Entities:
OBJECTIVES: To assess the effects of bimagrumab on skeletal muscle mass and function in older adults with sarcopenia and mobility limitations. DESIGN: A 24-week, randomized, double-blind, placebo-controlled, parallel-arm, proof-of-concept study. SETTING: Five centers in the United States. PARTICIPANTS: Community-dwelling adults (N = 40) aged 65 and older with gait speed between 0.4 and 1.0 m/s over 4 m and an appendicular skeletal muscle index of 7.25 kg/m2 or less for men and 5.67 kg/m2 or less for women. INTERVENTION: Intravenous bimagrumab 30 mg/kg (n = 19) or placebo (n = 21). MEASUREMENTS: Change from baseline in thigh muscle volume (TMV), subcutaneous and intermuscular fat, appendicular and total lean body mass, grip strength, gait speed, and 6-minute walk distance (6MWD). RESULTS: Thirty-two (80%) participants completed the study. TMV increased by Week 2, was sustained throughout the treatment period, and remained above baseline at the end of study in bimagrumab-treated participants, whereas there was no change with placebo treatment (Week 2: 5.15 ± 2.19% vs -0.34 ± 2.59%, P < .001; Week 4: 6.12 ± 2.56% vs 0.16 ± 3.42%, P < .001; Week 8: 8.01 ± 3.70% vs 0.35 ± 3.32%, P < .001; Week 16: 7.72 ± 5.31% vs 0.42 ± 5.14%, P < .001; Week 24: 4.80 ± 5.81% vs -1.01 ± 4.43%, P = .002). Participants with slower walking speed at baseline receiving bimagrumab had clinically meaningful and statistically significantly greater improvements in gait speed (mean 0.15 m/s, P = .009) and 6MWD (mean 82 m, P = .022) than those receiving placebo at Week 16. Adverse events in the bimagrumab group included muscle-related symptoms, acne, and diarrhea, most of which were mild in severity and resolved by the end of study. CONCLUSION: Treatment with bimagrumab over 16 weeks increased muscle mass and strength in older adults with sarcopenia and improved mobility in those with slow walking speed.
Authors: Michael I Polkey; Jens Praestgaard; Amy Berwick; Frits M E Franssen; Dave Singh; Michael C Steiner; Richard Casaburi; Hanns-Christian Tillmann; Estelle Lach-Trifilieff; Ronenn Roubenoff; Daniel S Rooks Journal: Am J Respir Crit Care Med Date: 2019-02-01 Impact factor: 21.405
Authors: Sophie L Allen; Jonathan I Quinlan; Amritpal Dhaliwal; Matthew J Armstrong; Ahmed M Elsharkawy; Carolyn A Greig; Janet M Lord; Gareth G Lavery; Leigh Breen Journal: Am J Physiol Gastrointest Liver Physiol Date: 2020-11-25 Impact factor: 4.052
Authors: Jason D Roh; Ryan Hobson; Vinita Chaudhari; Pablo Quintero; Ashish Yeri; Mark Benson; Chunyang Xiao; Daniel Zlotoff; Vassilios Bezzerides; Nicholas Houstis; Colin Platt; Federico Damilano; Brian R Lindman; Sammy Elmariah; Michael Biersmith; Se-Jin Lee; Christine E Seidman; Jonathan G Seidman; Robert E Gerszten; Estelle Lach-Trifilieff; David J Glass; Anthony Rosenzweig Journal: Sci Transl Med Date: 2019-03-06 Impact factor: 17.956