Intrahepatic Cholestasis of PregnancyPhase 2OASISNCT07823127
MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP)
A Phase 2 study testing Maralixibat in people with Intrahepatic Cholestasis of Pregnancy, run by Mirum Pharmaceuticals, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Intrahepatic Cholestasis of Pregnancy
- What is being tested?
- Maralixibat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2027to 12 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Medinfo Mirum contact
About this study
Official title: MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP) (OASIS)
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
- Being tested
- Maralixibat
- Medical subject headings
- Intrahepatic Cholestasis of Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaralixibatDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Maralixibat Treatment | Experimental | Participants will receive maralixibat tablets or oral solution. Receives: Drug: Maralixibat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Measured: From first dose until approximately 42 days after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start15 Jan 2027 (estimated)
- Primary completion12 Jan 2029 (estimated)
- Study completion12 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic Cholestasis of PregnancyStudies of the same condition, open and under way.
- More trials run by Mirum Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mirum Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823127
- Sponsor's protocol ID
- MRX-901
- Acronym
- OASIS
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP) (OASIS)
- ClinicalTrials.gov ID
- NCT07823127
- Acronym / sponsor ID
- OASIS / MRX-901
- Conditions
- Intrahepatic Cholestasis of Pregnancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mirum Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 12 Jan 2029 (estimated)
- Study completion
- 12 Jan 2029 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maralixibat Treatment | Experimental | Drug: MaralixibatParticipants will receive maralixibat tablets or oral solution. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaralixibatMaralixibat 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. | Drug | Maralixibat Treatment |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From first dose until approximately 42 days after delivery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Reference - Intrahepatic Cholestasis of PregnancyLink provided by the sponsor.
- Mirum Pharmaceuticals homepageLink provided by the sponsor.
- US FDA ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Intrahepatic Cholestasis of Pregnancy
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
Pregnancy Related
RecruitingObservational study
Bile Acids Metabolism and Genetic Mutation Profile in the Intrahepatic Cholestasis of Pregnacy in Indian Population
Intrahepatic Cholestasis of Pregnancy, Genetic Mutation
Not yet recruiting
The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy
Intrahepatic Cholestasis of Pregnancy
RecruitingObservational study
Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy
Intrahepatic Cholestasis of Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medinfo Mirum contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maralixibat in people with Intrahepatic Cholestasis of Pregnancy, run by Mirum Pharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Mirum (+16506674085, clinicaltrials@mirumpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: From first dose until approximately 42 days after delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.