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NCT01369511 Clinical Trial

A Study of LY2495655 in Older Participants Undergoing Elective Total Hip Replacement

Muscular Atrophy Clinical Trial

Official title:
A Phase 2 Randomized Study to Investigate the Efficacy and Safety of LY2495655 Versus Placebo in Older Patients Undergoing Elective Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01369511
Other study ID # 11671
Secondary ID I1Q-MC-JDDE
Status Completed
Phase Phase 2
First received
Last updated
Start date July 2011
Est. completion date February 2014

Study information
Verified date May 2018
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to test the hypothesis that appendicular lean body mass (aLBM) will increase after 12 weeks of LY2495655 treatment versus placebo in older participants undergoing elective total hip arthroplasty (eTHA).

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LY2495655
Administered subcutaneously
• Placebo
Administered subcutaneously
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Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Denmark,  Estonia,  Finland,  France,  Japan,  Spain,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12 The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by dual energy x-ray absorptiometry (DEXA). Least squares (LS) means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via a mixed-effects model for repeated measured (MMRM) analysis. Baseline, 12 Weeks
Secondary Change From Baseline in Appendicular Lean Body Mass (aLBM) at Weeks 4, 8, and 16 The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by DEXA. LS means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via an MMRM analysis. Baseline, 4 Weeks, 8 Weeks, and 16 Weeks
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