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Maralixibat for Intrahepatic Cholestasis of Pregnancy

NCT07389031 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-02-05

No results posted yet for this study

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

Interventions

DRUG

Maralixibat

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

Sponsors & Collaborators

  • Mirum Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Imperial College London

    lead OTHER

Principal Investigators

  • Catherine Williamson, MD · Imperial College London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-03-31
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07389031 on ClinicalTrials.gov