MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP)

NCT07823127 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MRX-901
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in pregnant women with intrahepatic cholestasis of pregnancy (ICP). This is an open-label study where all participants will receive maralixibat.

Conditions

Intrahepatic Cholestasis of Pregnancy

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  From first dose until approximately 42 days after delivery.

Study Arms (1)

Maralixibat Treatment

EXPERIMENTAL

Participants will receive maralixibat tablets or oral solution.

Drug: Maralixibat

Interventions

Maralixibat DRUG

Maralixibat tablets: 10 mg and 15 mg. Maralixibat oral solution 20 mg/mL. Maralixibat administered orally once or twice daily, with dose adjustments based on response and tolerability, from enrollment until delivery.

Maralixibat Treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to provide signed informed consent at the screening visit
• Female aged ≥18 and ≤45 years with viable singleton pregnancy between 20 weeks 0 days and no more than 35 weeks 0 days (inclusive) gestational age at the screening/baseline visit
• Have a diagnosis of ICP in line with the AASLD guidelines
• Willing and able to complete study-related procedures as required

You may not qualify if:

• At the time of the screening/baseline visit, decision has already been made to deliver within the next 7 days, for any indication.
• Known placenta accreta, complete placenta previa, PPROM at any gestational age prior to enrollment, cervical incompetence, history of prior spontaneous birth at ≤34 weeks gestational age not secondary to known or suspected ICP, or other condition (in the opinion of the investigator) likely to result in spontaneous or iatrogenic delivery before 37 weeks gestational age
• Known non-reassuring fetal status based upon antepartum testing (e.g., CTG (cardiotography) at or within 7 days prior to screening/baseline visit
• Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life
• Known History or evidence of current undelying cholestatic liver disease at screening/baseline (Note: Women with history of ICP or known pathogenic variants that predispose to ICP are considered eligible.)
• Evidence of other hepatobiliary conditions at screening or baseline.

Sponsors & Collaborators

• Mirum Pharmaceuticals, Inc.: lead

Related Links

• Reference - Intrahepatic Cholestasis of Pregnancy
• Mirum Pharmaceuticals homepage
• US FDA Resources

MeSH Terms

Conditions

Intrahepatic Cholestasis of Pregnancy

Interventions

maralixibat

Central Study Contacts

Clinical Trials Mirum

CONTACT

+16506674085; clinicaltrials@mirumpharma.com

Medinfo Mirum

CONTACT

medinfo@mirumpharma.com

Study Design

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

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): January 12, 2029
• Study Completion (Estimated): January 12, 2029
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share