Not Yet RecruitingPhase 2

Maralixibat for Intrahepatic Cholestasis of Pregnancy

United Kingdom28 participantsStarted 2026-04-01

Plain-language 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

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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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.

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.

What they're measuring

Assess the Safety and Tolerability of Maralixibat in Participants With ICP

Timeframe: Through to end of treatment, up to 21 weeks

Trial details

NCT IDNCT07389031

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-31

Contact for this trial

Jenny Chambers

07843 660349 jenny.chambers@imperial.ac.uk

View on ClinicalTrials.gov More Intrahepatic Cholestasis of Pregnancy trials