A Study of LY2495655 in Older Participants Undergoing Elective Total Hip Replacement (NCT01369511) | Clinical Trial Compass
CompletedPhase 2
A Study of LY2495655 in Older Participants Undergoing Elective Total Hip Replacement
United States400 participantsStarted 2011-07
Plain-language 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).
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* Males with a female partner of childbearing potential should use contraception during the treatment period of the trial and up to 15 weeks after the last dose of investigational product.
* Females should be of non-child bearing potential.
* Elective total hip arthroplasty (eTHA) is scheduled.
* Have a body mass index of \<40 kilograms per square meter (kg/m\^2) and a weight \<136.4 kilograms (kg).
* Can climb at least 6 stairs with or without holding the handrail (but without human assistance), according to the participant at screening.
* Can stand up from a chair and walk more than 10 meters without human assistance.
* Takes at least 12 seconds to perform the Timed Up and Go (TUG) test at screening.
Exclusion Criteria:
* Another inpatient surgical procedure is planned in the 6 months following randomization.
* Lower extremity amputation.
* Lower-limb fracture within 6 months prior to screening or any major lower-limb surgery within 3 months prior to randomization.
* Simultaneous bilateral eTHA.
* The planned surgical procedure will preclude weight bearing for at least 4 weeks postoperatively (for instance, the planned procedure will involve extensive bone grafting). "Partial weight-bearing" and "weight-bearing as tolerated" are acceptable, but "non weight-bearing," "touch weight-bearing," or "feather weight-bearing" are exclusive.
* Underlying muscle disease (for example, polymyositis or muscular dystrophy) or a history of muscle disease other than a…
What they're measuring
1
Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12