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NCT01341470
A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2495655 in Japanese Subjects
Phase 1 trial testing LY2495655 in Healthy Volunteer in 47 participants. Completed in 1 May 2012.
1 May 2012
Quick facts
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 47 |
| Start date | 1 May 2011 |
| Primary completion | 1 May 2012 |
| Estimated completion | 1 May 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- LY2495655 — full drug profile →
- Placebo
Conditions studied
- Healthy Volunteer — all drugs for Healthy Volunteer →
Sponsor
Eli Lilly and Company — full company profile →
Who can join
Adults 24 to 85, any sex, with Healthy Volunteer. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Participants With Clinically Significant Effects
Time frame: Baseline to study completion (up to 135 days)
Clinically significant effects are defined as treatment emergent adverse events (TEAEs) which in the opinion of the investigator are thought to be possibly related to study drug. A summary of serious and all other non-serious adverse events (whether or not related to study drug) is located in the Reported Adverse Events module.
Sponsor's own description
The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of LY2495655 administered subcutaneously and intravenously in Japanese subjects.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT01341470
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Eli Lilly and Company trials
Trials by the same sponsor.
- NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
- NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
- NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
- NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
- NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01341470 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
- Last refreshed: 15 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01341470.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing