Rezdiffra pregnancy and breastfeeding registry for women with NASH
A Phase 4, Decentralized Observational Registry to Evaluate the Safety in Women With NASH and Their Infants Exposed to REZDIFFRA™ (Resmetirom) During Pregnancy and/or Lactation
This registry collects information about pregnancy and infant health for women with NASH who were exposed to Rezdiffra during pregnancy or while breastfeeding.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Sex | Female |
| Sponsor | Madrigal Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 1 site (West Conshohocken, Pennsylvania) |
| Trial ID | NCT07541469 on ClinicalTrials.gov |
What this trial studies
The Rezdiffra Pregnancy and Lactation Registry is a worldwide observational registry that collects information on women with metabolic dysfunction-associated steatohepatitis (MASH/NASH) who received resmetirom (Rezdiffra) during pregnancy or lactation and on their infants through 12 months of age. Participants provide IRB/IEC-approved consent and study staff record timing of exposure (including exposure within 3 days before conception), pregnancy outcomes, maternal clinical course, and infant health and developmental outcomes up to one year. The registry is sponsored by Madrigal Pharmaceuticals and enrolls participants via the sponsor location in West Conshohocken, Pennsylvania, with no protocol-specified exclusions. Collected data aim to inform clinicians and regulators about the safety profile of Rezdiffra in pregnancy and breastfeeding.
Who should consider this trial
Good fit: Women with NASH who received at least one dose of resmetirom within three days before conception or at any time during pregnancy or while breastfeeding, and their infants up to 12 months of age, are eligible.
Not a fit: Patients who were never exposed to Rezdiffra or whose infants are older than 12 months are unlikely to receive direct benefit from participation or the registry findings.
Why it matters
Potential benefit: If successful, the registry could provide real-world safety data to help inform treatment decisions for pregnant or breastfeeding women with NASH and their healthcare providers.
How similar studies have performed: Pregnancy registries for other medications have generated useful safety signals in the past, but controlled evidence in pregnant women with NASH is limited, so this registry addresses an existing data gap.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female patients with NASH who have been exposed to at least 1 dose of resmetirom at any time during pregnancy (defined as having received resmetirom within 3 days prior to the date of conception and/or during pregnancy) and/or during lactation, and their infants (up to 12 months of age). 2. Patient or parent/legally authorized representative must be able to understand and provide consent through an Institutional Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent or assent form. Exclusion Criteria: NONE
Where this trial is running
West Conshohocken, Pennsylvania
- Madrigal Pharmaceuticals — West Conshohocken, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Madrigal Pharmaceuticals
- Email: MHGSafety@iconplc.com
- Phone: 800-905-0324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.