Monitoring the effects of bempedoic acid during pregnancy
A Post-marketing, Long-term, Observational, Descriptive Study to Assess the Risk of Pregnancy and Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Women Exposed to Bempedoic Acid or Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) During Pregnancy
This study looks at how bempedoic acid affects pregnant women and their babies during pregnancy and the first year of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Esperion Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Morrisville, North Carolina) |
| Trial ID | NCT05103254 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on pregnant females who have been exposed to bempedoic acid or a fixed combination of bempedoic acid and ezetimibe. It aims to collect data on the outcomes of these pregnancies and the health of infants during their first year of life. The study will gather information on both maternal and infant health to better understand the implications of bempedoic acid exposure during pregnancy. Participants will be monitored throughout their pregnancy and for a year after giving birth.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women who have taken at least one dose of bempedoic acid or the bempedoic acid/ezetimibe combination during their pregnancy.
Not a fit: Patients who have not been exposed to bempedoic acid or the combination therapy during pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effects of bempedoic acid during pregnancy, guiding future treatment options for pregnant women with hyperlipidemia.
How similar studies have performed: While there may be limited data on the specific effects of bempedoic acid during pregnancy, similar observational studies on drug exposure in pregnancy have provided important safety information in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Exposure to at least 1 dose of bempedoic acid or bempedoic acid/ezetimibe FCDP at any time during pregnancy (from first day of last menstrual period \[LMP\] to pregnancy outcome Exclusion Criteria:
Where this trial is running
Morrisville, North Carolina
- Evidera, PPD business unit — Morrisville, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Esperion Therapuetics
- Email: Bempedoic.Acid.PSP@ppd.com
- Phone: 1 833 377 7633 (Option 5)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.