NCT01524224

A Phase 1 Dose-Escalation Study of LY2495655, an Anti-Myostatin Monoclonal Antibody, in Patients With Advanced Cancer

Completed Phase 1 Results posted Last updated 4 January 2019

What this trial tests

Phase 1 trial testing LY2495655 in Advanced Cancer in 29 participants. Completed in 1 January 2016.

Timeline

1 January 2008

Primary endpoint
1 November 2012

1 January 2016

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	1 January 2008
Primary completion	1 November 2012
Estimated completion	1 January 2016
Sites	7 locations across United States

Drugs / interventions tested

• LY2495655 — full drug profile →

Conditions studied

• Advanced Cancer — all drugs for Advanced Cancer →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Advanced Cancer. 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.

• Number of Participants With One or More Drug-related Adverse Events
  Time frame: Baseline through End of Study (up to 51 months)
  A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.

Sponsor's own description

This study is a multicenter, open-label, dose-escalation phase 1 study of intravenous (IV) LY2495655 in participants with advanced cancer.

Publications & conference data

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

1. Beyond TGFβ: roles of other TGFβ superfamily members in cancer.
   Wakefield LM, Hill CS. · · 2013 · cited 321× · PMID 23612460 · DOI 10.1038/nrc3500
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. Molecular Pathways: Cachexia Signaling-A Targeted Approach to Cancer Treatment.
   Miyamoto Y, Hanna DL, Zhang W, Baba H, et al · · 2016 · cited 89× · PMID 27340276 · DOI 10.1158/1078-0432.ccr-16-0495
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. Management of Cancer Cachexia: Attempting to Develop New Pharmacological Agents for New Effective Therapeutic Options.
   Marceca GP, Londhe P, Calore F. · · 2020 · cited 63× · PMID 32195193 · DOI 10.3389/fonc.2020.00298
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. Glucocorticoids counteract hypertrophic effects of myostatin inhibition in dystrophic muscle.
   Hammers DW, Hart CC, Patsalos A, Matheny MK, et al · · 2020 · cited 29× · PMID 31830002 · DOI 10.1172/jci.insight.133276