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NCT06021951 · ClinicalTrials.gov registry record · Phase 4
Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women
A Phase 4 study, sponsored by Esperion Therapeutics.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT06021951: Completed Phase 4 study, sponsored by Esperion Therapeutics.
NCT06021951 is a Phase 4 study that has completed, run by Esperion Therapeutics. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06021951, a Phase 4 study, has completed, sponsored by Esperion Therapeutics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study is designed to characterize the excretion of bempedoic acid or bempedoic acid and ezetimibe into mature breast milk of healthy lactating women and assess the exposure to the breast fed infant by estimating the daily infant dosage and the relative infant dose (RID) of bempedoic acid or bempedoic acid and ezetimibe in breast milk after 6 consecutive daily doses of bempedoic acid or bempedoic acid/ezetimibe FCDP.
Primary Outcome
Daily infant dosage of study drug was calculated for Bempedoic Acid arm and FCDP arm respectively from the cumulative amount of study drug (bempedoic acid or bempedoic acid and ezetimibe) excreted in breast milk over 24 hours.
Interventions
- DRUG Bempedoic Acid 180 MG Oral Tablet
- DRUG Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-08-04 |
| Est. Completion | 2024-03-22 |
| Phase | Phase 4 |
What the finished NCT06021951 record still lists
NCT06021951 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Bempedoic Acid 180 MG Oral Tablet is the first listed.
NCT06021951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06021951 about?
NCT06021951 is a clinical study titled "Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women". This study is designed to characterize the excretion of bempedoic acid or bempedoic acid and ezetimibe into mature breast milk of healthy lactating women and assess the exposure to the breast fed infant by estimating the daily infant dosage and the relative infant dose (RID) of bempedoic acid or bem...
What is the current status of trial NCT06021951?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2023-08-04. Estimated completion is 2024-03-22.
What interventions are being tested in trial NCT06021951?
The interventions under investigation include: Bempedoic Acid 180 MG Oral Tablet (DRUG), Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT06021951?
This trial is sponsored by Esperion Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06021951's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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