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

NCT06021951 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1002FDC-075
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Lactating Women

Keywords

Bempedoic acid; Ezetimibe; Bempedoic acid and ezetimibe; Breast Milk

Outcome Measures

Primary Outcomes (2)

• Daily Infant Dose

  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.

  24 hours post Day 6 dose administration

• Relative Infant Dose (RID)

  Relevant Infant Dose (RID) (calculated as the ratio of estimated infant daily dose per kg body weight and maternal daily dose per kg of body weight multiplied by 100) was analyzed for the Bempedoic Acid arm and FCDP arm respectively. Maternal dosage is the ratio of bempedoic acid dose or ezetimibe dose administered daily divided by maternal body weight at baseline.

  24 hours post Day 6 dose administration

Secondary Outcomes (16)

• Cumulative Amount of Bempedoic Acid (ETC-1002) and Metabolites (ESP-15228, ETC-1002-Glucuronide) in Breast Milk

  24 hours post Day 6 dose administration

• Cumulative Amount of Ezetimibe (EZE) and Metabolite (EZE-Glucuronide) in Breast Milk

  24 hours post Day 6 dose administration

• Maximum Concentrations (Cmax) of Bempedoic Acid and Metabolites in Breast Milk

  24 hours post Day 6 dose administration

• Cmax of Ezetimibe and Metabolite in Breast Milk

  24 hours post Day 6 dose administration

• Time of Maximum Concentration (Tmax) of Bempedoic Acid and Metabolites in Breast Milk

  24 hours post Day 6 dose administration

Study Arms (2)

Bempedoic acid

EXPERIMENTAL

Drug: Bempedoic Acid 180 MG Oral Tablet

Bempedoic acid/ezetimibe fixed combination drug product

EXPERIMENTAL

Drug: Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet

Interventions

Bempedoic Acid 180 MG Oral Tablet DRUG

Bempedoic Acid 180 MG Oral Tablet \[Nexletol\]

Also known as: Nexletol

Bempedoic acid

Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet DRUG

Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet \[NEXLIZET\]

Also known as: Nexlizet 180 mg-10 mg

Bempedoic acid/ezetimibe fixed combination drug product

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject must be a lactating female who had a normal full-term pregnancy and has been actively breastfeeding or pumping for at least 4 weeks; lactation must be well established per Investigator discretion.
• The subject must be willing to pump regularly during the study to maintain milk supply and discontinue breastfeeding for the entire 13-day Treatment and Washout Periods.
• The subject must not be pregnant.
• The subject must be surgically sterile or willing to use 1 acceptable method of birth control.

You may not qualify if:

• Has clinically significant infection (e.g., pneumonia, pyelonephritis) or chronic infection within 30 days prior to enrollment.
• Has evidence of unstable or uncontrolled, clinically significant cardiovascular, central nervous system, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder, including serious allergy, asthma, hypoxemia, hypertension, seizures, or allergic skin rash, that, in the opinion of the Investigator, would confound the study results or compromise subject safety.
• Has estimated glomerular filtration rate (eGFR) \<30 mL/min/1.732 using the Modification of Diet in Renal Disease (MDRD) formula.
• Has liver disease or dysfunction characterized by Child-Pugh Class B or Class C.
• History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
• Has active psychiatric problems that, in the Investigator's opinion, may interfere with compliance with the study procedures.
• Has history of breast implants, breast augmentation, or breast reduction surgery.
• Has a prior history of difficulty establishing lactation.
• Gastrointestinal conditions or procedures (including weight loss surgery; e.g., Lap-Band® or gastric bypass) that may affect drug absorption.
• Any history of malignancy (with the exception only of basal or squamous cell carcinoma of the skin in individuals that have been cancer free for \>5 years).
• History within the last 2 years of drug, alcohol, amphetamine and derivatives, or cocaine abuse.
• Current smoker.
• Blood donation, participation in a multiple blood draw clinical study, major trauma, or surgery with or without blood loss within 30 days prior to enrollment.
• Blood transfusion for any reason within 90 days prior to enrollment.
• Use of any 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor (statin) concurrently or within 30 days prior to randomization.

Sponsors & Collaborators

• Esperion Therapeutics, Inc.: lead

Study Sites (1)

PPD Development, Las Vegas Research Unit

Las Vegas, Nevada, 89113, United States

Location

MeSH Terms

Interventions

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Medical Director
• Organization: Esperion Therapeutics, Inc.

medinfo@esperion.com

1-833-377-7633

Study Officials

• Christine Broestl, MS

  Esperion Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 1, 2023
• Study Start: August 4, 2023
• Primary Completion: February 21, 2024
• Study Completion: March 22, 2024
• Last Updated: April 11, 2025
• Results First Posted: April 11, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)