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Phase 2 Completed N=400 Randomized Double-blind Treatment

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

Muscular Atrophy
Source: ClinicalTrials.gov NCT01369511 ↗
Enrolled (actual)
400
Serious AEs
10.3%
Results posted
Jun 2018
Primary outcomePrimary: Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12 — 0.297; 0.741; 1.018; 1.357 percentage change in aLBM (3 limbs) — p=0.527

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).

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12
0.297; 0.741; 1.018; 1.357 0.527
SECONDARY
Change From Baseline in Appendicular Lean Body Mass (aLBM) at Weeks 4, 8, and 16
NA; NA; NA; NA; -0.900; -0.680 0.751

Eligibility Criteria

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 100 beats per minute [bpm]) at rest despite medical or device therapy, 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.
  • Any history of congestive heart failure within 6 months of screening.
  • 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.
  • Known history or presence of severe acute or chronic liver disease.
  • History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance <30 milliliters per minute (mL/minute) at screening.
  • Current evidence or recent history of significant psychiatric disease such as dementia/Alzheimer's disease, schizophrenia, or bipolar disorder.
  • Are currently enrolled in, or discontinued within the last 30 days (or 5 half-lives whichever is longer) from a clinical trial involving an investigational drug or off-label use of a drug, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Regularly uses known drugs of abuse and/or shows positive findings on urinary drug screening (physician prescribed narcotics are allowed).
  • Have a positive fecal occult blood (FOB) test at screening or cannot provide a stool sample for FOB testing prior to randomization.
  • Have uncontrolled diabetes mellitus.
  • Have had ocular trauma, ophthalmologic surgery, or eye laser treatment within 6 months prior to randomization.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01369511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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