Rezdiffra pregnancy and breastfeeding registry for women with NASH
Official title: 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
Run by Madrigal Pharmaceuticals, Inc. · NCT07541469 · Data updated 2026-11-12
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 |
|---|---|
| Sex | Women only |
| Enrollment | 10 (estimated) |
| Sponsor | Madrigal Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 1 site (West Conshohocken, Pennsylvania) |
| Status | Recruiting |
| Started | March 4, 2026 |
| Main results expected | April 8, 2030 |
| Study ends | April 8, 2030 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT07541469 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Madrigal Pharmaceuticals
West Conshohocken, Pennsylvania, United States Recruiting
Study contacts
- Study coordinator: Madrigal Pharmaceuticals
- Email: MHGSafety@iconplc.com
- Phone: 800-905-0324
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Rezdiffra with diabetes and pioglitazone or dapagliflozin in adults with MASH and F2-F3 fibrosis
This study tests whether Rezdiffra (resmetirom) can be safely used together with common diabetes medicines in adults with MASH and moderate to advanced liver fibrosis.
-
Resmetirom for MASH with HFpEF in adults
This study tests whether resmetirom can be given safely and show liver-related effects in adults with MASH and heart failure with preserved ejection fraction over 24 weeks.
-
MWN105 injection in overweight or obese adults you may join
This early-phase trial tests whether MWN105 is safe and tolerable in overweight or obese adults in China, using a placebo comparison.
-
Resmetirom in children and teens with MASH
This study tests how safe resmetirom is and how it acts in the body of kids aged 6 to 17 who have MASH with liver fibrosis.
-
Liver Inflammation Index test for MASH in adults with T2DM and MAFLD
This study tests a Liver Inflammation Index to see if it can identify MASH in adults who have both type 2 diabetes and MAFLD.
-
HSK31679 in MASH: a phase 3 test for safety and liver improvement
This phase 3 trial tests whether HSK31679 helps people with MASH compared to a placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.