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New hope for Moms-to-Be: drug targets dangerous pregnancy itch

NCT ID NCT07389031

Symptom relief Sponsor: Imperial College London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a drug called maralixibat in 28 pregnant women with intrahepatic cholestasis of pregnancy (ICP), a liver condition that causes severe itching and high bile acids. The main goal is to see if the drug is safe and tolerable for both mother and baby. Researchers will also check if it helps reduce itching and lower bile acid levels.

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 28 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 50 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. Provide signed informed consent and be willing to comply with all study visits and requirements through end of study, including the follow-up period 2. Female aged ≥18 and ≤50 years with a viable singleton pregnancy between 20 weeks 0 days and 34 weeks 0 days (inclusive) at the screening visit, and no more than 35 weeks 0 days (inclusive) at the baseline visit. 3. Diagnosis of ICP 4. Non fasting (e.g., postprandial) tSBA level ≥19 μmol/L as assessed by the local laboratory. 5. Meets all inclusion criteria and no exclusion criteria at screening as well as at the Day 1 (baseline) visit, unless otherwise specified. Exclusion Criteria: 1. At the time of either the screening or baseline visit, decision has already been made to deliver within the next 7 days, for any indication. 2. Known non-reassuring fetal status based upon antepartum testing (e.g., NST/CTG) at or within 7 days before the baseline visit. 3. Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life. 4. Participating in another ongoing interventional clinical study at screening or planning to participate in another contemporaneous interventional clinical study while participating in this study.

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Conditions

The condition(s) this trial relates to.

cholestasis intrahepatic cholestasis of pregnancy Pruritus

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

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Birmingham Womens and Childrens NHS Foundation Trust

    Birmingham, B15 2TG, United Kingdom

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE 1 7EH, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.