A Phase 2 interventional study of Maralixibat in Intrahepatic Cholestasis of Pregnancy, sponsored by Imperial College London. Not yet recruiting at 2 sites in United Kingdom. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Imperial College London · Phase 2, Interventional, and Treatment
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
26 studies on the registry are indexed under Intrahepatic Cholestasis of Pregnancy; 10 are open to participants now.
Browse Intrahepatic Cholestasis of Pregnancy studies →Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose-titrated open-label maralixibat, with primary assessment at Week 3; participants may continue treatment until delivery
Drug: Maralixibat
Oral solution, dose-titrated. Maralixibat is an ileal bile acid transporter (IBAT) inhibitor.
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 .
Time frame: Through to end of treatment, up to 21 weeks
Mean Change in the Weekly Average Worst Daily Itch Score as Measured by the Adult Itch Reported Outcome (5-D Itch Scale)
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)
Time frame: Through the end of treatment (up to 21 weeks).
Mean Change in Total Serum Bile Acid (tSBA) Concentration
Mean change from baseline to Week 3 of the study treatment period in total tSBA concentration (minimum 7 days).
Time frame: Baseline to Week 3 (minimum 7 days of treatment)
Proportion of participants with a Composite Adverse Perinatal Outcome
Number of adverse outcomes recorded from baseline to birth visit/end of study
Time frame: Up to 28 days after delivery
Plan to share: No
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This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Maralixibat
Intrahepatic Cholestasis of Pregnancy →