NCT01369511

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

Completed Phase 2 Results posted Last updated 4 May 2018

What this trial tests

Phase 2 trial testing LY2495655 in Muscular Atrophy in 400 participants. Completed in 1 February 2014.

Timeline

1 July 2011

Primary endpoint
1 February 2014

1 February 2014

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	400
Start date	1 July 2011
Primary completion	1 February 2014
Estimated completion	1 February 2014
Sites	45 locations across United States, Austria, Belgium, Canada, Denmark, Estonia, Finland, France

Drugs / interventions tested

• LY2495655 — full drug profile →
• Placebo

Conditions studied

• Muscular Atrophy — all drugs for Muscular Atrophy →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

50 and older, any sex, with Muscular Atrophy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12
  Time frame: Baseline, 12 Weeks
  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

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Myostatin inhibitors as therapies for muscle wasting associated with cancer and other disorders.
   Smith RC, Lin BK. · · 2013 · cited 118× · PMID 24157714 · DOI 10.1097/spc.0000000000000013
2. Muscle Wasting Diseases: Novel Targets and Treatments.
   Furrer R, Handschin C. · · 2019 · cited 75× · PMID 30148697 · DOI 10.1146/annurev-pharmtox-010818-021041
3. Myostatin/Activin Receptor Ligands in Muscle and the Development Status of Attenuating Drugs.
   Rodgers BD, Ward CW. · · 2022 · cited 68× · PMID 34520530 · DOI 10.1210/endrev/bnab030
4. Therapeutic applications and challenges in myostatin inhibition for enhanced skeletal muscle mass and functions.
   Wetzlich B, Nyakundi BB, Yang J. · · 2025 · cited 37× · PMID 39340593 · DOI 10.1007/s11010-024-05120-y
5. Pathogenesis, Intervention, and Current Status of Drug Development for Sarcopenia: A Review.
   Jang JY, Kim D, Kim ND. · · 2023 · cited 36× · PMID 37371730 · DOI 10.3390/biomedicines11061635
6. The Potential of SARMs and Antimyostatin Agents in Addressing Lean Body Mass Loss From GLP-1 Agonists: A Literature Review.
   Wen J, Ansari U, Shehabat M, Ansari Z, et al · · 2025 · cited 4× · PMID 40739991 · DOI 10.1111/1753-0407.70119
7. Sarcopenia and Muscle Aging: Updated Insights into Molecular Mechanisms and Translational Therapeutics.
   Nguyen TT, Dao T, Nguyen HT, Park JH, et al · · 2026 · cited 1× · PMID 41674227 · DOI 10.3803/enm.2025.2656
8. Development of pharmacological interventions for the treatment of sarcopenia.
   Yang D, Su L, Zhang L, Li Y, et al · · 2026 · PMID 42164047 · DOI 10.21037/atm-2025-1-184