Intrahepatic Cholestasis of PregnancyPhase 2METAPHORNCT07389031
Maralixibat for Intrahepatic Cholestasis of Pregnancy
A Phase 2 study testing Maralixibat in people with Intrahepatic Cholestasis of Pregnancy, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
An open label phase 2a/b trial of maralixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Intrahepatic Cholestasis of Pregnancy
- What is being tested?
- Maralixibat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Apr 2026to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Provide signed informed consent and be willing to comply with all study visits and requirements through end of study, including the follow-up period
- 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.
- Diagnosis of ICP
- Non fasting (e.g., postprandial) tSBA level ≥19 μmol/L as assessed by the local laboratory.
- Meets all inclusion criteria and no exclusion criteria at screening as well as at the Day 1 (baseline) visit, unless otherwise specified.
Who cannot join
- 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.
- Known non-reassuring fetal status based upon antepartum testing (e.g., NST/CTG) at or within 7 days before the baseline visit.
- Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life.
- Participating in another ongoing interventional clinical study at screening or planning to participate in another contemporaneous interventional clinical study while participating in this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites
Birmingham Womens and Childrens NHS Foundation Trust
Birmingham, B15 2TG
Guy's and St Thomas' NHS Foundation Trust
London, SE 1 7EH
About this study
Official title: Maralixibat for the trEatment of inTrAhePatic cHOlestasis of pRegnancy (METAPHOR)
An open label phase 2a/b trial of maralixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability
- Conditions
- Intrahepatic Cholestasis of Pregnancy
- Being tested
- Maralixibat
- Keywords
- Pruritus, Itch, Itching, Cholestasis, Bile Acid, Pregnancy, Pregnant, Intrahepatic, Liver
- Medical subject headings
- Intrahepatic Cholestasis of Pregnancy, Pruritus, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaralixibatDrug
Oral solution, dose-titrated. Maralixibat is an ileal bile acid transporter (IBAT) inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Maralixibat | Experimental | Dose-titrated open-label maralixibat, with primary assessment at Week 3; participants may continue treatment until delivery Receives: Drug: Maralixibat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Safety and Tolerability of Maralixibat in Participants With ICP
To assess the safety and tolerability of maralixibat in participants with ICP on the basis of the following endpoints:
Proportion of participants experiencing one or more of the following:
To assess the safety and tolerability of maralixibat for the treatment of intrahepatic cholestasis of pregnancy (ICP) in pregnant women.
Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs that lead to discontinuation
Incidence of clinically relevant laboratory abnormalities .
Measured: Through to end of treatment, up to 21 weeks
Secondary outcomes (2)
Mean Change in the Weekly Average Worst Daily Itch Score as Measured by the Adult Itch Reported Outcome (5-D Itch Scale)
Mean change from baseline to Week 3 (minimum 7 days) of the study treatment period in the weekly average worst daily itch score as measured by the Adult Itch Reported Outcome (5-D Itch Scale)
Measured: Through the end of treatment (up to 21 weeks).
Mean Change in Total Serum Bile Acid (tSBA) Concentration
Mean change from baseline to Week 3 of the study treatment period in total tSBA concentration (minimum 7 days).
Measured: Baseline to Week 3 (minimum 7 days of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic Cholestasis of PregnancyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Mirum Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Catherine Williamson, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389031
- Sponsor's protocol ID
- 1012589
- Other IDs
- X
- Acronym
- METAPHOR
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maralixibat for the trEatment of inTrAhePatic cHOlestasis of pRegnancy (METAPHOR)
- ClinicalTrials.gov ID
- NCT07389031
- Acronym / sponsor ID
- METAPHOR / 1012589
- Conditions
- Intrahepatic Cholestasis of Pregnancy
- Keywords
- Pruritus, Itch, Itching, Cholestasis, Bile Acid, Pregnancy, Pregnant, Intrahepatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Mirum Pharmaceuticals, Inc.
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label phase 2a/b trial of maralixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maralixibat | Experimental | Drug: MaralixibatDose-titrated open-label maralixibat, with primary assessment at Week 3; participants may continue treatment until delivery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provide signed informed consent and be willing to comply with all study visits and requirements through end of study, including the follow-up period
- 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.
- Diagnosis of ICP
- Non fasting (e.g., postprandial) tSBA level ≥19 μmol/L as assessed by the local laboratory.
- Meets all inclusion criteria and no exclusion criteria at screening as well as at the Day 1 (baseline) visit, unless otherwise specified.
Key exclusion criteria (4 listed)
- 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.
- Known non-reassuring fetal status based upon antepartum testing (e.g., NST/CTG) at or within 7 days before the baseline visit.
- Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life.
- Participating in another ongoing interventional clinical study at screening or planning to participate in another contemporaneous interventional clinical study while participating in this study.
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 |
|---|---|---|
| MaralixibatOral solution, dose-titrated. Maralixibat is an ileal bile acid transporter (IBAT) inhibitor. | Drug | Maralixibat |
Primary outcome
Assess the Safety and Tolerability of Maralixibat in Participants With ICP
Time frame: Through to end of treatment, up to 21 weeks
To assess the safety and tolerability of maralixibat in participants with ICP on the basis of the following endpoints: Proportion of participants experiencing one or more of the following: To assess the safety and tolerability of maralixibat for the treatment of intrahepatic cholestasis of pregnancy (ICP) in pregnant women. Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs that lead to discontinuation Incidence of clinically relevant laboratory abnormalities .
2 secondary outcomes
Mean Change in the Weekly Average Worst Daily Itch Score as Measured by the Adult Itch Reported Outcome (5-D Itch Scale)
Time frame: Through the end of treatment (up to 21 weeks).
Mean Change in Total Serum Bile Acid (tSBA) Concentration
Time frame: Baseline to Week 3 (minimum 7 days of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Catherine Williamson, MD principal investigator
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maralixibat in people with Intrahepatic Cholestasis of Pregnancy, run by Imperial College London at 2 sites in United Kingdom.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Chambers (07843 660349, jenny.chambers@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the Safety and Tolerability of Maralixibat in Participants With ICP (time frame: Through to end of treatment, up to 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2026.