NCT01604408

A Phase 2 Randomized Study to Investigate the Efficacy and Safety of LY2495655 Versus Placebo in Older Patients Who Have Fallen Recently and Have Muscle Weakness

Completed Phase 2 Results posted Last updated 24 March 2018

What this trial tests

Phase 2 trial testing LY2495655 in Muscle Weakness in 201 participants. Completed in 1 December 2013.

Timeline

1 May 2012

Primary endpoint
1 September 2013

1 December 2013

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	201
Start date	1 May 2012
Primary completion	1 September 2013
Estimated completion	1 December 2013
Sites	22 locations across United States, Argentina, Australia, France, Germany, Sweden

Drugs / interventions tested

• LY2495655 — full drug profile →
• Placebo

Conditions studied

• Muscle Weakness — all drugs for Muscle Weakness →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

75 and older, any sex, with Muscle Weakness. 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 to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM)
  Time frame: Baseline to 24 weeks
  Change from baseline to 24-week endpoint in aLBM, as measured by dual energy x-ray absorptiometry (DEXA), is presented. Least squares (LS) means were calculated using a mixed model repeated measures (MMRM) with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline aLBM as covariate.

Sponsor's own description

LY2495655 is an investigational drug being tested for muscle wasting.

Publications & conference data

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

1. Myostatin antibody (LY2495655) in older weak fallers: a proof-of-concept, randomised, phase 2 trial.
   Becker C, Lord SR, Studenski SA, Warden SJ, et al · · 2015 · cited 280× · PMID 26516121 · DOI 10.1016/s2213-8587(15)00298-3
2. 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
3. Muscle Wasting Diseases: Novel Targets and Treatments.
   Furrer R, Handschin C. · · 2019 · cited 75× · PMID 30148697 · DOI 10.1146/annurev-pharmtox-010818-021041
4. 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
5. Advances in research on pharmacotherapy of sarcopenia.
   Feike Y, Zhijie L, Wei C. · · 2021 · cited 41× · PMID 34553120 · DOI 10.1002/agm2.12168
6. 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
7. 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
8. Emerging molecular mediators and targets for age-related skeletal muscle atrophy.
   Brown LA, Guzman SD, Brooks SV. · · 2020 · cited 15× · PMID 32243876 · DOI 10.1016/j.trsl.2020.03.001