Clinical Trial: Dose Range Finding Study of Bimagrumab in Sarcopenia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A 28 Week, Randomized, Double-blind, Placebo-controlled, Two-part, Multi-center, Parallel Group Dose Range Finding Study to Assess the Effect of Monthly Doses of Bimagrumab 70, 210, and 700 mg on Skel

Brief Summary: The purpose of this study is 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 will generate data on the safety, tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Short Physical Performance Battery [ Time Frame: Baseline, week 25 ]

Change from baseline to week 25.


Original Primary Outcome: 6 minute walk test [ Time Frame: Baseline, week 25 ]

Change from baseline to week 25.


Current Secondary Outcome:

  • Safety and tolerability as assessed by various measures such as adverse events [ Time Frame: baseline, weeks 1, 5, 9, 13, 17, 21 and 25 ]
    Assessed by various measures such as adverse events over 24 weeks.
  • 6-minute walk test [ Time Frame: baseline, week 25 ]
    Change from baseline to week 25
  • Gait speed [ Time Frame: baseline, week 25 ]
    Change from baseline to Week 25
  • Total lean body mass and appendicular skeletal muscle index measured by DXA [ Time Frame: baseline, week 25 ]
    Change from baseline to Week 25


Original Secondary Outcome:

  • Safety and tolerability as assessed by various measures such as adverse events [ Time Frame: baseline, weeks 1, 5, 9, 13, 17, 21 and 25 ]
    Assessed by various measures such as adverse events over 24 weeks.
  • Short Physical Performance Battery [ Time Frame: baseline, week 25 ]
    Change from baseline to week 25
  • Gait speed [ Time Frame: baseline, week 25 ]
    Change from baseline to Week 25
  • Total lean body mass and appendicular skeletal muscle index measured by DXA [ Time Frame: baseline, week 25 ]
    Change from baseline to Week 25


Information By: Novartis

Dates:
Date Received: December 10, 2014
Date Started: December 9, 2014
Date Completion: January 13, 2019
Last Updated: April 12, 2017
Last Verified: April 2017