NCT07541469RecruitingAccepts Healthy Volunteers

Rezdiffra Pregnancy and Lactation Registry

Madrigal Pharmaceuticals, Inc.

Start Date

3/4/2026

Completion Date

4/8/2030

Summary

To evaluate pregnancy and clinical outcomes in women with NASH and their infants after exposure to Rezdiffra at any time during pregnancy and/or lactation.

Detailed Description

The purpose of the Rezdiffra™ Pregnancy and Lactation Registry is to create a worldwide information source, called a pregnancy registry. The registry will collect information about the safety of Rezdiffra™ (resmetirom), an approved medication, during pregnancy and/or while breastfeeding. This will help doctors and other healthcare providers learn more about its effect on pregnant and breastfeeding women and their infant after delivery up to 12 months of age.

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

DRUG

Rezdiffra

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Conditions

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Locations

Madrigal Pharmaceuticals

West Conshohocken, Pennsylvania 19428

United States