NCT01601600

A Multi-center Study to Assess the Effects of BYM338 on Skeletal Muscle in Sarcopenic Adults

A Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Effects of BYM338 on Skeletal Muscle in Sarcopenic Adults With Mobility Limitations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Proof of Concept study is to determine the effects of BYM338 on skeletal muscle volume, mass, and strength and patient function (gait speed) in non-demented elderly adults with sarcopenia and mobility limitations. In addition, this study will generate data on the safety, tolerability, and pharmacokinetics of BYM338 in older adults and its response on additional physical function measures in this population. Furthermore, the extended study duration will provide information on the stability of BYM-induced changes in skeletal muscle and patient function in this subgroup of the older population.

Conditions

• Skeletal Muscle

Interventions

Type	Name	Description
DRUG	BYM338	BYM338
DRUG	Placebo	BYM338 Placebo

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-05-18
• Last updated: 2020-12-17

Locations

5 sites across 1 country: United States