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

Inclusion criteria

• 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

Exclusion criteria

• 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.