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NCT Number: NCT07389031

Maralixibat for Intrahepatic Cholestasis of Pregnancy

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

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Key information

Conditions

Intrahepatic Cholestasis of Pregnancy Bile Duct Diseases Biliary Tract Diseases Cholestasis Digestive System Diseases Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham Womens and Childrens NHS Foundation Trust, Birmingham, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Maralixibat

Drug

Oral solution, dose-titrated. Maralixibat is an ileal bile acid transporter (IBAT) inhibitor.

Primary outcomes

  1. 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 .

Secondary outcomes

  1. 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 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)

  2. Mean Change in Total Serum Bile Acid (tSBA) Concentration

    Time frame: Baseline to Week 3 (minimum 7 days of treatment)

    Mean change from baseline to Week 3 of the study treatment period in total tSBA concentration (minimum 7 days).

Other outcomes

  1. Proportion of participants with a Composite Adverse Perinatal Outcome

    Time frame: Up to 28 days after delivery

    Number of adverse outcomes recorded from baseline to birth visit/end of study

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny Chambers

CONTACT

[email protected]

07843 660349

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Mirum Pharmaceuticals, Inc.

Registry information

Official study title

Maralixibat for the trEatment of inTrAhePatic cHOlestasis of pRegnancy (METAPHOR)

Acronym: METAPHOR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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