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NCT01144377 · ClinicalTrials.gov registry record · Phase 2
A Study of LY2541546 in Women With Low Bone Mineral Density
A Phase 2 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 154
- Enrollment target
NCT01144377: Completed Phase 2 study, sponsored by Eli Lilly and Company.
NCT01144377 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 154 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01144377, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 154 participants
- Enrollment target
Study 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).
Primary Outcome
Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance. Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate.
Interventions
- DRUG Placebo
- DRUG LY2541546
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2010-08 |
| Est. Completion | 2013-02 |
| Phase | Phase 2 |
What the finished NCT01144377 record still lists
NCT01144377 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01144377 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01144377 about?
NCT01144377 is a clinical study titled "A Study of LY2541546 in Women With Low Bone Mineral Density". 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) ...
What is the current status of trial NCT01144377?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2010-08. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01144377?
The interventions under investigation include: Placebo (DRUG), LY2541546 (DRUG).
Who is sponsoring clinical trial NCT01144377?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01144377's enrollment target sits among peer trials
154 448th of 2000 higher than 1,552 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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