Maralixibat for Intrahepatic Cholestasis of Pregnancy

NCT07389031 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 1012589X
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Intrahepatic Cholestasis of Pregnancy

Keywords

Pruritus; Itch; Itching; Cholestasis; Bile Acid; Pregnancy; Pregnant; Intrahepatic; Liver

Outcome Measures

Primary Outcomes (1)

• 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 .

  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)

  Through the end of treatment (up to 21 weeks).

• Mean Change in Total Serum Bile Acid (tSBA) Concentration

  Baseline to Week 3 (minimum 7 days of treatment)

Other Outcomes (1)

• Proportion of participants with a Composite Adverse Perinatal Outcome

  Up to 28 days after delivery

Study Arms (1)

Maralixibat

EXPERIMENTAL

Dose-titrated open-label maralixibat, with primary assessment at Week 3; participants may continue treatment until delivery

Drug: Maralixibat

Interventions

Maralixibat DRUG

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

Maralixibat

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mirum Pharmaceuticals, Inc.: collaborator
• Imperial College London: lead

Study Sites (2)

Birmingham Womens and Childrens NHS Foundation Trust

Birmingham, B15 2TG, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE 1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Intrahepatic Cholestasis of Pregnancy; Pruritus; Cholestasis

Interventions

maralixibat

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Catherine Williamson, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Chambers

CONTACT

07843 660349; jenny.chambers@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 5, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)