Healthy Lactating WomenPhase 4NCT06021951

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 testing Bempedoic Acid 180 MG Oral Tablet and Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet in people with Healthy Lactating Women, run by Esperion Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy Lactating Women
What is being tested?: Bempedoic Acid 180 MG Oral Tablet and Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 4 Aug 2023to 22 Mar 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 19Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

PPD Development, Las Vegas Research Unit
Las Vegas, Nevada, 89113

Other trials in United States

About this study

Official title: An Open-Label Postmarking Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid and Ezetimibe in the Breast Milk of Healthy Lactating Women Administered Therapeutic Doses of Bempedoic Acid or Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP)

Read the detailed description

Post marketing approval commitment for the FDA

Conditions: Healthy Lactating Women
Being tested: Bempedoic Acid 180 MG Oral Tablet, Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet
Keywords: Bempedoic acid, Ezetimibe, Bempedoic acid and ezetimibe, Breast Milk

What participants receive

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

Bempedoic Acid 180 MG Oral TabletDrug
Also called Nexletol
Bempedoic Acid 180 MG Oral Tablet [Nexletol]
Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral TabletDrug
Also called Nexlizet 180 mg-10 mg
Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet [NEXLIZET]

Study groups in NCT06021951
Study group	Role	What they receive
Bempedoic acid	Experimental	Not described Receives: Drug: Bempedoic Acid 180 MG Oral Tablet
Bempedoic acid/ezetimibe fixed combination drug product	Experimental	Not described Receives: Drug: Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet

What is being measured

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

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.
Measured: 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.
Measured: 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
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.
Measured: 24 hours post Day 6 dose administration
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).
Measured: 24 hours post Day 6 dose administration
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
Measured: 24 hours post Day 6 dose administration
Cmax of Ezetimibe and Metabolite in Breast Milk
Cmax of Ezetimibe, and EZE-glucuronide analyzed in FCDP arm only.
Measured: 24 hours post Day 6 dose administration
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
Measured: 24 hours post Day 6 dose administration
Tmax of Ezetimibe and Metabolite in Breast Milk
Tmax of Ezetimibe and EZE-glucuronide in Breast Milk were analyzed for FCDP arm only.
Measured: 24 hours post Day 6 dose administration
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.
Measured: 24 hours post Day 6 dose administration
AUC24h of Ezetimibe and Metabolite in Breast Milk
AUC24h of Ezetimibe and EZE-glucuronide in Breast Milk were analyzed for FCDP arm only.
Measured: 24 hours post Day 6 dose administration
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.
Measured: 24 hours post Day 6 dose administration
Cavg of Ezetimibe and Metabolite in Breast Milk
Cavg of Ezetimibe and EZE-glucuronide in Breast Milk were analyzed for FCDP arm only.
Measured: 24 hours post Day 6 dose administration
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.
Measured: 24 hours post Day 6 dose administration
Ctrough of Ezetimibe and Metabolite in Breast Milk
Ctrough_milk of Ezetimibe and EZE-glucuronide were analyzed for FCDP arm only.
Measured: 24 hours post Day 6 dose administration
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.
Measured: 24 hours post Day 6 dose administration
Ctrough of Ezetimibe and Metabolite in Plasma
Ctrough_plasma of Ezetimibe and EZE-glucuronide were analyzed for FCDP arm only.
Measured: 24 hours post Day 6 dose administration
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.
Measured: 24 hours post Day 6 dose administration
M/P Ratio of Ezetimibe and Metabolite
M/P Ratio of Ezetimibe and EZE-glucuronide were analyzed for FCDP arm only.
Measured: 24 hours post Day 6 dose administration

Timeline

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

4 Aug 202322 Mar 2024

First posted1 Sep 2023
Study start4 Aug 2023
Primary completion21 Feb 2024
Study completion22 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy Lactating WomenStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06021951
Sponsor's protocol ID: 1002FDC-075
Status last verified: May 2024
First submitted: 27 Aug 2023
Last updated: 11 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women
Urinary Tract Infections
RecruitingPhase 1
A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women
Healthy
RecruitingPhase 4
Evaluation of the Excretion of Fosfomycin Into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women
Healthy Lactating Women
RecruitingPhase 1
A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
Healthy Participants
Not yet recruitingPhase 2/3
Postpartum 8-aminoquinoline Breast Milk Study
Drug Pharmacokinetics in Healthy Volunteers

All Healthy Lactating Women trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Postmarking Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid and Ezetimibe in the Breast Milk of Healthy Lactating Women Administered Therapeutic Doses of Bempedoic Acid or Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP)
ClinicalTrials.gov ID: NCT06021951
Acronym / sponsor ID: 1002FDC-075
Conditions: Healthy Lactating Women
Keywords: Bempedoic acid, Ezetimibe, Bempedoic acid and ezetimibe, Breast Milk
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Esperion Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 4 Aug 2023 (actual)
Primary completion: 21 Feb 2024 (actual)
Study completion: 22 Mar 2024 (actual)
First posted: 1 Sep 2023 (actual)
Results: Posted 11 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Post marketing approval commitment for the FDA

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bempedoic Acid 180 MG Oral TabletAlso: NexletolBempedoic Acid 180 MG Oral Tablet [Nexletol]	Drug	Bempedoic acid
Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral TabletAlso: Nexlizet 180 mg-10 mgBempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet [NEXLIZET]	Drug	Bempedoic acid/ezetimibe fixed combination drug product

Primary outcome

Daily Infant Dose
Time frame: 24 hours post Day 6 dose administration
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.
Relative Infant Dose (RID)
Time frame: 24 hours post Day 6 dose administration
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.

16 secondary outcomes

Cumulative Amount of Bempedoic Acid (ETC-1002) and Metabolites (ESP-15228, ETC-1002-Glucuronide) in Breast Milk
Time frame: 24 hours post Day 6 dose administration
Cumulative Amount of Ezetimibe (EZE) and Metabolite (EZE-Glucuronide) in Breast Milk
Time frame: 24 hours post Day 6 dose administration
Maximum Concentrations (Cmax) of Bempedoic Acid and Metabolites in Breast Milk
Time frame: 24 hours post Day 6 dose administration
Cmax of Ezetimibe and Metabolite in Breast Milk
Time frame: 24 hours post Day 6 dose administration
Time of Maximum Concentration (Tmax) of Bempedoic Acid and Metabolites in Breast Milk
Time frame: 24 hours post Day 6 dose administration
Tmax of Ezetimibe and Metabolite in Breast Milk
Time frame: 24 hours post Day 6 dose administration
Area Under the Breast Milk Concentration-time Curve Over the 24-hour Collection Interval (AUC24h) of Bempedoic Acid and Metabolites in Breast Milk
Time frame: 24 hours post Day 6 dose administration
AUC24h of Ezetimibe and Metabolite in Breast Milk
Time frame: 24 hours post Day 6 dose administration
Average Concentration (Cavg) of Bempedoic Acid and Metabolites in Breast Milk
Time frame: 24 hours post Day 6 dose administration
Cavg of Ezetimibe and Metabolite in Breast Milk
Time frame: 24 hours post Day 6 dose administration
Trough Concentration (Ctrough) of Bempedoic Acid and Metabolites in Breast Milk
Time frame: 24 hours post Day 6 dose administration
Ctrough of Ezetimibe and Metabolite in Breast Milk
Time frame: 24 hours post Day 6 dose administration
Ctrough of Bempedoic Acid and Metabolites in Plasma
Time frame: 24 hours post Day 6 dose administration
Ctrough of Ezetimibe and Metabolite in Plasma
Time frame: 24 hours post Day 6 dose administration
Ctrough_milk/Ctrough_plasma (M/P Ratio) of Bempedoic Acid and Metabolites
Time frame: 24 hours post Day 6 dose administration
M/P Ratio of Ezetimibe and Metabolite
Time frame: 24 hours post Day 6 dose administration

Results and safety

Results posted to the registry on 11 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bempedoic Acid	8	8
Bempedoic Acid/Ezetimibe FCDP	8	8

Primary outcome: Daily Infant Dose

Time frame: 24 hours post Day 6 dose administration. Mean (Standard Deviation). Unit: Milligrams per day

Measure	Bempedoic Acid n = 8	Bempedoic Acid (FCDP) n = 8	Ezetimibe (FCDP) n = 8
Value	0.0331 (0.0210)	0.0337 (0.0286)	0.0002 (0.0002)

Population analysed: 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.

Primary outcome: Relative Infant Dose (RID)

Time frame: 24 hours post Day 6 dose administration. Mean (Standard Deviation). Unit: Percentage of maternal dose

Measure	Bempedoic Acid n = 8	Bempedoic Acid (FCDP) n = 8	Ezetimibe (FCDP) n = 8
Value	0.4790 (0.1962)	0.4678 (0.2889)	0.0370 (0.0097)

Population analysed: Pharmacokinetic Analysis Set.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 43. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bempedoic Acid	0 of 8 (0%)	4 of 8 (50%)	0 of 8
Bempedoic Acid / Ezetimibe FCDP	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Healthy Lactating Women

RecruitingPhase 1
A Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women
Urinary Tract Infections
RecruitingPhase 1
A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women
Healthy
RecruitingPhase 4
Evaluation of the Excretion of Fosfomycin Into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women
Healthy Lactating Women
RecruitingPhase 1
A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
Healthy Participants
Not yet recruitingPhase 2/3
Postpartum 8-aminoquinoline Breast Milk Study
Drug Pharmacokinetics in Healthy Volunteers

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christine Broestl, MS study director

Esperion Therapeutics, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 19 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: finished, as of the sponsor's last update on 11 Apr 2025. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily Infant Dose (time frame: 24 hours post Day 6 dose administration). The study lists 2 primary outcomes in all. 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 NCT06021951.

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 11 Apr 2025.