Clinical Trial: A Study in Older Participants Who Have Fallen and Have Muscle Weakness
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2 Randomized Study to Investigate the Efficacy and Safety of LY2495655 Versus Placebo in Older Patients Who Have Fallen Recently and Have Muscle Weakness
Brief Summary: LY2495655 is an investigational drug being tested for muscle wasting. Muscle wasting includes shrinking of the muscle and weakness. This can occur when a muscle is no longer as active as usual. When muscles are no longer in use, they become weaker.
Detailed Summary:
Sponsor: Eli Lilly and Company
Current Primary Outcome: Change from Baseline to 24 week endpoint in appendicular Lean Body Mass (aLBM) [ Time Frame: Baseline, 24 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from Baseline in Stair Climbing (StC) Score [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks ]
- Change from Baseline in Repeated Chair Stands (RCS) Score [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks ]
- Change from Baseline in Usual Gait Speed (uGS) at 4 Meters [ Time Frame: Baseline, 12 weeks, 24 weeks, 36 weeks ]
Original Secondary Outcome: Same as current
Information By: Eli Lilly and Company
Dates:
Date Received: May 21, 2012
Date Started: May 2012
Date Completion:
Last Updated: April 14, 2014
Last Verified: December 2013