Disuse atrophy MedDRA version: 14.1 Level: LLT Classification code 10013521 Term: Disuse muscle atrophy System Organ Class: 100000004859
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males or females age 50 years or older. Elective total hip arthroplasty (eTHA) is scheduled. Have a body mass index of =65 years) yes F.1.3.1 Number of subjects for this age range 324
Exclusion criteria
Exclusion criteria: 1. Another inpatient surgical procedure is planned in the 6 months following the randomization visit. 2. Lower extremity amputation. 3. Lower limb fracture within 6 months prior to the screening visit or any major lower limb surgery within 3 months prior to randomisation. 4. Simultaneous bilateral eTHA. 5. 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. 6. Underlying muscle disease (for example, polymyositis or muscular dystrophy) or a history of muscle disease other than age-associated muscle waste or disuse atrophy. 7. Recent neurologic injury (100 beats per minute) at rest despite medical or device therapy, or any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for 30 seconds) despite medical or device therapy, or any history of resuscitated cardiac arrest or the presence of an automatic internal cardioverter-defibrillator. 14. Any history of congestive heart failure within 6 months of the screening visit. 15. Systolic blood pressure >160 or 100 or 2 times the upper limit of normal (ULN), or alkaline phosphatase >1.5 times ULN, or total bilirubin >1.5 times ULN. The liver tests above may be re
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 patients undergoing elective total hip arthroplasty (eTHA).;Secondary Objective: see Exploratory objectives in the study protocol.;Primary end point(s): Change from baseline in appendicular lean body mass.;Timepoint(s) of evaluation of this end point: 12 weeks after the first injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): pls see in the study protocol: exploratory endpoints;Timepoint(s) of evaluation of this end point: pls see in the study protocol: exploratory endpoints | — |
Countries
Canada, Denmark, Estonia, Finland, France, Japan, Sweden, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed