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Can an experimental drug ease a pregnancy liver condition?

NCT ID NCT07823127

Symptom relief Sponsor: Mirum Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Intrahepatic cholestasis of pregnancy is a liver condition that causes severe itching and can pose risks to both mother and baby. Researchers are testing whether an oral drug called maralixibat is safe and well tolerated in pregnant women with this condition. All 15 participants receive maralixibat from enrollment until delivery, and researchers track side effects and how the drug is handled by the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
maralixibat, an experimental oral drug
What this could lead to
If it works, maralixibat could offer pregnant women with this liver condition a way to manage their symptoms until delivery.
What could go wrong
This is a small Phase 2 study with 15 participants and no control group, so it cannot prove the drug works. Researchers do not yet know how maralixibat affects a developing baby.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Willing and able to provide signed informed consent at the screening visit 2. Female aged ≥18 and ≤45 years with viable singleton pregnancy between 20 weeks 0 days and no more than 35 weeks 0 days (inclusive) gestational age at the screening/baseline visit 3. Have a diagnosis of ICP in line with the AASLD guidelines 4. Willing and able to complete study-related procedures as required Exclusion Criteria: 1. At the time of the screening/baseline visit, decision has already been made to deliver within the next 7 days, for any indication. 2. Known placenta accreta, complete placenta previa, PPROM at any gestational age prior to enrollment, cervical incompetence, history of prior spontaneous birth at ≤34 weeks gestational age not secondary to known or suspected ICP, or other condition (in the opinion of the investigator) likely to result in spontaneous or iatrogenic delivery before 37 weeks gestational age 3. Known non-reassuring fetal status based upon antepartum testing (e.g., CTG (cardiotography) at or within 7 days prior to screening/baseline visit 4. Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life 5. Known History or evidence of current undelying cholestatic liver disease at screening/baseline (Note: Women with history of ICP or known pathogenic variants that predispose to ICP are considered eligible.) 6. Evidence of other hepatobiliary conditions at screening or baseline.

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Conditions

The condition(s) this trial relates to.

intrahepatic cholestasis of pregnancy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intrahepatic cholestasis of pregnancy

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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