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PregnancyNCT05103254

Bempedoic Acid Pregnancy Surveillance Program

An observational study of Pregnancy and Hyperlipidemias, run by Esperion Therapeutics, Inc. at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Bempedoic acid pregnancy surveillance program Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy, Hyperlipidemias
What is being tested?
Bempedoic Acid and Bempedoic Acid / Ezetimibe
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Sep 2021to May 2032
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Adult, Older adult

Study population: Primary care

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Esperion Therapuetics contact

1 833 377 7633 (Option 5)

Bempedoic.Acid.PSP@ppd.com

United States1 site, 1 recruiting

  • Evidera, PPD business unit

    Morrisville, North Carolina, 27560

    Recruiting

Other trials in United States

About this study

Official title: 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

Bempedoic acid pregnancy surveillance program

Read the detailed description

A surveillance study of females exposed to bempedoic acid or bempedoic acid/ezetimibe fixed combination drug product (FCDP) during pregnancy. Observational outcome data will be collected on pregnant females through pregnancy and infants through the first year of life.

Being tested
Bempedoic Acid, Bempedoic Acid / Ezetimibe
Keywords
bempedoic acid
Medical subject headings
Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bempedoic AcidDrug

    Also called Nexletol

    Bempedoic Acid 180 MG

  • Bempedoic Acid / EzetimibeDrug

    Also called Nexlizet

    Bempedoic Acid 180 MG / Ezetimibe 10 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major congenital malformations (MCM)

    An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention (CDC 2019a). MCMs will be defined and coded with criteria specified by US CDC Metropolitan Atlanta Congenital Defects Program (MACDP).

    Measured: Birth up to 12 months

Secondary outcomes (8)

  1. Minor congenital malformation

    An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual (CDC 2019a). The surveillance program defines and codes minor congenital malformations with criteria specified as defined by CDC (CDC 2017).

    Measured: Birth up to 12 months

  2. Spontaneous abortion

    An involuntary fetal loss or the expulsion of the products of conception occurring at < 20 gestational weeks.

    Measured: Time of conception up to birth

  3. Stillbirth

    As defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary fetal loss occurring at ≥ 20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥ 350 g.

    Measured: Time of conception up to birth

  4. Elective termination

    A voluntary fetal loss or interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health or due to fetal abnormalities.

    Measured: Time of conception up to birth

  5. Preterm birth

    A live birth occurring at < 37 gestational weeks.

    Measured: Time of conception up to birth

  6. Small for gestational age (SGA)

    Weight at birth in < 10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants (Battaglia 1967). For the determination of SGA, the surveillance program will utilize the sex-specific international growth reference standards from the International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH-21st) for those born between 240/7 and 426/7 gestational weeks (Villar 2014; Villar 2016). The INTERGROWTH-21st standards are the latest available global reference standards, representing contemporary information from an international, multiethnic, diverse population, and have been specifically developed for modern research.

    Measured: Birth up to 12 months

  7. Postnatal growth deficiency

    Weight in < 10th percentile for sex and chronological age using standard growth charts. Postnatal growth deficiency will be evaluated at 4 and 12 months of infant age. For the determination of postnatal growth deficiency, the surveillance program will utilize the sex-specific international growth reference standards from the World Health Organization for children ages 0 to 24 months. The World Health Organization growth standards are recommended for use in the US for infants and children 0 to 2 years of age (CDC 2010).

    Measured: Birth up to 12 months

  8. Infant development deficiency

    Failure to achieve the developmental milestones for chronological age, as defined by the CDC (CDC 2019b). Infant developmental deficiency will be evaluated at 4 and 12 months of infant age for each CDC-defined category (social/emotional, language/communication, cognitive, and movement/physical development), separately.

    Measured: Birth up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2021
  2. Study start1 Sep 2021
  3. Primary completionMay 2032 (estimated)
  4. Study completionMay 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05103254
Sponsor's protocol ID
1002-074
Status last verified
May 2024
First submitted
21 Oct 2021
Last updated
17 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
Individual data sharing
Undecided

Publications

  • Paponja K, Pecin I, Reiner Z, Banach M. Bempedoic acid: new evidence and recommendations on use. Curr Opin Lipidol. 2024 Feb 1;35(1):41-50. doi: 10.1097/MOL.0000000000000911. Epub 2023 Dec 8.

    PubMed 38085172

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy and Hyperlipidemias, run by Esperion Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Esperion Therapuetics (1 833 377 7633 (Option 5), Bempedoic.Acid.PSP@ppd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major congenital malformations (MCM) (time frame: Birth up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05103254, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.

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