Milk-Only Lactation Study to Evaluate the Concentration o... | NCT06021951

NCT06021951

Status Module

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Bempedoic Acid 180 MG Oral Tablet	Drug	Bempedoic Acid 180 MG Oral Tablet [Nexletol]	Bempedoic acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Cumulative Amount of Bempedoic Acid (ETC-1002) and Metabolites (ESP-15228, ETC-1002-Glucuronide) in Breast Milk	Cumulative amount of ETC-1002, ESP-15228, and ETC-1002-glucuronide excreted in breast milk during the 24-hour collection period were analyzed for the Bempedoic Acid arm and FCDP arm respectively.	24 hours post Day 6 dose administration

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Use of cyclosporine, cholestyramine, probenecid, fibrate drugs, or medications contraindicated during lactation concurrently or within 30 days prior to randomization.
Concomitant use or use within 30 days prior to randomization of drugs that decrease breast milk production, such as pseudoephedrine.
Concomitant use or use within 30 days prior to randomization of drugs that increase breast milk production, such as domperidone.
Use of any experimental or investigational drugs/vaccines concurrently or within 30 days or 5 half-lives of the drug, whichever is longer, prior to screening.

Name	Affiliation	Role
Christine Broestl, MS	Esperion Therapeutics, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
PPD Development, Las Vegas Research Unit		Las Vegas	Nevada	89113	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Bempedoic Acid	Participants received bempedoic acid 180 mg oral tablet for 6 days
FG001	Bempedoic Acid/Ezetimibe FCDP	Participants received bempedoic acid 180 mg/ezetimibe 10 mg FCDP oral tablets for 6 days

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 6, 2023	Mar 25, 2025

ID	Title	Description
BG000	Bempedoic Acid	Participants received bempedoic acid 180 mg oral tablet for 6 days
BG001	Bempedoic Acid/Ezetimibe FCDP	Participants received bempedoic acid 180 mg/ezetimibe 10 mg FCDP oral tablets for 6 days
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0008 BG0018 BG00216

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00033.5± 4.17 BG00127.1± 4.09 BG00230.3± 5.17

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0008 BG0018 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0013 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Pharmacokinetic Analysis Set comprised of all participants in Full Analysis Set who had at least 1 evaluable post-dosing breast milk bempedoic acid pharmacokinetic concentration data point.

Posted

Mean

Standard Deviation

Milligrams per day

24 hours post Day 6 dose administration

ID	Title	Description
OG000	Bempedoic Acid	Bempedoic Acid Arm
OG001	Bempedoic Acid (FCDP)	Bempedoic Acid / Ezetimibe FCDP Arm
OG002	Ezetimibe (FCDP)	Bempedoic Acid / Ezetimibe FCDP Arm

Units	Counts
Participants	OG0008 OG0018 OG0028

Title

Denominators

Categories

Title	Measurements
	OG0000.0331± 0.0210 OG0010.0337± 0.0286 OG0020.0002± 0.0002

Primary

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.

Pharmacokinetic Analysis Set.

Posted

Mean

Standard Deviation

Percentage of maternal dose

24 hours post Day 6 dose administration

ID	Title	Description
OG000	Bempedoic Acid	Bempedoic Acid Arm
OG001	Bempedoic Acid (FCDP)	Bempedoic Acid / Ezetimibe FCDP Arm
OG002	Ezetimibe (FCDP)	Bempedoic Acid / Ezetimibe FCDP Arm

Units	Counts
Participants

Secondary

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

Cumulative amount of ETC-1002, ESP-15228, and ETC-1002-glucuronide excreted in breast milk during the 24-hour collection period were analyzed for the Bempedoic Acid arm and FCDP arm respectively.

Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.

Posted

Mean

Standard Deviation

Nanograms

24 hours post Day 6 dose administration

ID	Title	Description
OG000	ETC-1002	Bempedoic Acid Arm
OG001	ESP-15228	Bempedoic Acid Arm
OG002	ETC-1002-Glucuronide	Bempedoic Acid Arm
OG003	ETC-1002 (FCDP)	Bempedoic Acid / Ezetimibe FCDP Arm
OG004	ESP-15228 (FCDP)

Secondary

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

Cumulative amount of Ezetimibe, and EZE-glucuronide excreted in breast milk during 24-hour collection period were analyzed (FCDP arm only).

Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.

Posted

Mean

Standard Deviation

Nanograms

24 hours post Day 6 dose administration

ID	Title	Description
OG000	Ezetimibe	Bempedoic Acid / Ezetimibe FCDP Arm
OG001	EZE-Glucuronide	Bempedoic Acid / Ezetimibe FCDP Arm

Units	Counts
Participants	OG000

Secondary

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

Cmax of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively

Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanograms per milliliter

24 hours post Day 6 dose administration

ID	Title	Description
OG000	ETC-1002	Bempedoic Acid Arm
OG001	ESP-15228	Bempedoic Acid Arm
OG002	ETC-1002-Glucuronide	Bempedoic Acid Arm
OG003	ETC-1002 (FCDP)	Bempedoic Acid / Ezetimibe FCDP Arm
OG004	ESP-15228 (FCDP)

Secondary

Cmax of Ezetimibe and Metabolite in Breast Milk

Cmax of Ezetimibe, and EZE-glucuronide analyzed in FCDP arm only.

Pharmacokinetic Analysis Set.

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanograms per milliliter

24 hours post Day 6 dose administration

ID	Title	Description
OG000	Ezetimibe	Bempedoic Acid / Ezetimibe FCDP Arm
OG001	EZE-Glucuronide	Bempedoic Acid / Ezetimibe FCDP Arm

Units	Counts
Participants	OG000

Secondary

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

Tmax of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively

Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.

Posted

Median

Full Range

Hours

24 hours post Day 6 dose administration

ID	Title	Description
OG000	ETC-1002	Bempedoic Acid Arm
OG001	ESP-15228	Bempedoic Acid Arm
OG002	ETC-1002-Glucuronide	Bempedoic Acid Arm
OG003	ETC-1002 (FCDP)	Bempedoic Acid / Ezetimibe FCDP Arm
OG004	ESP-15228 (FCDP)	Bempedoic Acid / Ezetimibe FCDP Arm

Secondary

Tmax of Ezetimibe and Metabolite in Breast Milk

Tmax of Ezetimibe and EZE-glucuronide in Breast Milk were analyzed for FCDP arm only.

Pharmacokinetic Analysis Set.

Posted

Median

Full Range

Hours

24 hours post Day 6 dose administration

ID	Title	Description
OG000	Ezetimibe	Bempedoic Acid / Ezetimibe FCDP Arm
OG001	EZE-Glucuronide	Bempedoic Acid / Ezetimibe FCDP Arm

Units	Counts
Participants	OG000

Secondary

Area Under the Breast Milk Concentration-time Curve Over the 24-hour Collection Interval (AUC24h) of Bempedoic Acid and Metabolites in Breast Milk

AUC24h of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively.

Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*nanograms per milliliter

24 hours post Day 6 dose administration

ID	Title	Description
OG000	ETC-1002	Bempedoic Acid Arm
OG001	ESP-15228	Bempedoic Acid Arm
OG002	ETC-1002-Glucuronide	Bempedoic Acid Arm
OG003	ETC-1002 (FCDP)	Bempedoic Acid / Ezetimibe FCDP Arm
OG004	ESP-15228 (FCDP)

Secondary

AUC24h of Ezetimibe and Metabolite in Breast Milk

AUC24h of Ezetimibe and EZE-glucuronide in Breast Milk were analyzed for FCDP arm only.

Pharmacokinetic Analysis Set.

Posted

Geometric Least Squares Mean

Geometric Coefficient of Variation

Hours*nanograms per milliliter

24 hours post Day 6 dose administration

ID	Title	Description
OG000	Ezetimibe	Bempedoic Acid / Ezetimibe FCDP Arm
OG001	EZE-Glucuronide	Bempedoic Acid / Ezetimibe FCDP Arm

Units	Counts
Participants	OG000

Secondary

Average Concentration (Cavg) of Bempedoic Acid and Metabolites in Breast Milk

Cavg (defined as AUC24h/24h) of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively.

Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanograms per milliliter

24 hours post Day 6 dose administration

ID	Title	Description
OG000	ETC-1002	Bempedoic Acid Arm
OG001	ESP-15228	Bempedoic Acid Arm
OG002	ETC-1002-Glucuronide	Bempedoic Acid Arm
OG003	ETC-1002 (FCDP)	Bempedoic Acid / Ezetimibe FCDP Arm
OG004	ESP-15228 (FCDP)

Secondary

Cavg of Ezetimibe and Metabolite in Breast Milk

Cavg of Ezetimibe and EZE-glucuronide in Breast Milk were analyzed for FCDP arm only.

Pharmacokinetic Analysis Set.

Posted

Geometric Least Squares Mean

Geometric Coefficient of Variation

Nanograms per milliliter

24 hours post Day 6 dose administration

ID	Title	Description
OG000	Ezetimibe	Bempedoic Acid / Ezetimibe FCDP Arm
OG001	EZE-Glucuronide	Bempedoic Acid / Ezetimibe FCDP Arm

Units	Counts
Participants	OG000

Secondary

Trough Concentration (Ctrough) of Bempedoic Acid and Metabolites in Breast Milk

Ctrough_milk of ETC-1002, ESP-15228, and ETC-1002-glucuronide were analyzed for Bempedoic Acid arm and FCDP arm respectively.

Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanograms per milliliter

24 hours post Day 6 dose administration

ID	Title	Description
OG000	ETC-1002	Bempedoic Acid Arm
OG001	ESP-15228	Bempedoic Acid Arm
OG002	ETC-1002-Glucuronide	Bempedoic Acid Arm
OG003	ETC-1002 (FCDP)	Bempedoic Acid / Ezetimibe FCDP Arm
OG004	ESP-15228 (FCDP)

Secondary

Ctrough of Ezetimibe and Metabolite in Breast Milk

Ctrough_milk of Ezetimibe and EZE-glucuronide were analyzed for FCDP arm only.

Pharmacokinetic Analysis Set.

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanograms per milliliter

24 hours post Day 6 dose administration

ID	Title	Description
OG000	Ezetimibe	Bempedoic Acid / Ezetimibe FCDP Arm
OG001	EZE-Glucuronide	Bempedoic Acid / Ezetimibe FCDP Arm

Units	Counts
Participants	OG000

Secondary

Ctrough of Bempedoic Acid and Metabolites in Plasma

Ctrough_plasma of ETC-1002, ESP-15228, and ETC-1002-glucuronide were analyzed for Bempedoic Acid arm and FCDP arm respectively.

Pharmacokinetic Analysis Set.

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanograms per milliliter

24 hours post Day 6 dose administration

ID	Title	Description
OG000	ETC-1002	Bempedoic Acid Arm
OG001	ESP-15228	Bempedoic Acid Arm
OG002	ETC-1002-Glucuronide	Bempedoic Acid Arm
OG003	ETC-1002 (FCDP)	Bempedoic Acid / Ezetimibe FCDP Arm
OG004	ESP-15228 (FCDP)	Bempedoic Acid / Ezetimibe FCDP Arm

Secondary

Ctrough of Ezetimibe and Metabolite in Plasma

Ctrough_plasma of Ezetimibe and EZE-glucuronide were analyzed for FCDP arm only.

Pharmacokinetic Analysis Set.

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanograms per milliliter

24 hours post Day 6 dose administration

ID	Title	Description
OG000	Ezetimibe	Bempedoic Acid / Ezetimibe FCDP Arm
OG001	EZE-Glucuronide	Bempedoic Acid / Ezetimibe FCDP Arm

Units	Counts
Participants	OG000

Secondary

Ctrough_milk/Ctrough_plasma (M/P Ratio) of Bempedoic Acid and Metabolites

M/P Ratio of ETC-1002, ESP-15228, and ETC-1002-glucuronide were analyzed for Bempedoic Acid arm and FCDP arm respectively.

Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

24 hours post Day 6 dose administration

ID	Title	Description
OG000	ETC-1002	Bempedoic Acid Arm
OG001	ESP-15228	Bempedoic Acid Arm
OG002	ETC-1002-Glucuronide	Bempedoic Acid Arm
OG003	ETC-1002 (FCDP)	Bempedoic Acid / Ezetimibe FCDP Arm
OG004	ESP-15228 (FCDP)	Bempedoic Acid / Ezetimibe FCDP Arm

Secondary

M/P Ratio of Ezetimibe and Metabolite

M/P Ratio of Ezetimibe and EZE-glucuronide were analyzed for FCDP arm only.

Pharmacokinetic Analysis Set.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

24 hours post Day 6 dose administration

ID	Title	Description
OG000	Ezetimibe	Bempedoic Acid / Ezetimibe FCDP Arm
OG001	EZE-Glucuronide	Bempedoic Acid / Ezetimibe FCDP Arm

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	MedDRA (26.0)	Non-systematic Assessment	EG0001 affected8 at risk EG0011 affected8 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (26.0)	Non-systematic Assessment	EG0000 affected8 at risk EG0012 affected8 at risk
Vomiting	Gastrointestinal disorders	MedDRA (26.0)	Non-systematic Assessment	EG0000 affected8 at risk EG0012 affected8 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (26.0)	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected8 at risk
Nausea	Gastrointestinal disorders	MedDRA (26.0)	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected8 at risk
Asthenia	General disorders	MedDRA (26.0)	Non-systematic Assessment	EG0000 affected8 at risk EG0012 affected8 at risk
Rhinitis	Infections and infestations	MedDRA (26.0)	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected8 at risk
Alanine aminotransferase increased	Investigations	MedDRA (26.0)	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected8 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (26.0)	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected8 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected8 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected8 at risk
Headache	Nervous system disorders	MedDRA (26.0)	Non-systematic Assessment	EG0002 affected8 at risk EG0010 affected8 at risk
Dizziness	Nervous system disorders	MedDRA (26.0)	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected8 at risk

ID	Term
C581236	8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
D013607	Tablets

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bempedoic Acid	Participants received bempedoic acid 180 mg oral tablet for 6 days	0	8	0	8	4	8
EG001	Bempedoic Acid / Ezetimibe FCDP	Participants received bempedoic acid 180 mg/ezetimibe 10 mg FCDP oral tablets for 6 days	0	8	0	8	3	8