CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 154 enrolled
Drug / intervention
LY2541546 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01144377
NCT01144377Phase 2Completed
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A Phase 2 Randomized Study of LY2541546 Versus Placebo in Postmenopausal Women With Low Bone Mineral Density: An Evaluation of the Dose Response Relationship Using Bone Mineral Density

Eli Lilly and Company·interventional·Posted Jun 15, 2010·Updated Sep 17, 2019

In Brief

A Phase 2 clinical trial evaluating LY2541546 and Placebo for Osteoporosis. Completed, enrolled 154 participants across 8 sites in 5 countries.

Detailed Summary

The primary objectives of this study include evaluating the dose response of LY2541546 using bone mineral density (BMD) change from baseline as compared to placebo and evaluating the overall safety and tolerability of LY2541546 following multiple subcutaneous administrations in postmenopausal (PMP) women with low BMD. Following the last dose of study drug, participants will be able to participate in a 12 month extension to collect additional safety and efficacy data (no further treatment will be administered during this extension).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesDenmark, Estonia, Japan, Lithuania, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 15, 2010
Enrollment StartAug 1, 2010
Primary CompletionMay 1, 2012
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.0 years ago

Interventions

LY2541546drug

Administered subcutaneously

Placebodrug

Administered subcutaneously