Rezdiffra Pregnancy and Lactation Registry

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.

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Key information

Conditions

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Sex eligibility

Female

Study type

Observational

Primary location

Madrigal Pharmaceuticals

West Conshohocken, Pennsylvania, 19428, United States

Location status: Recruiting

Location contact

Event Reporting Desk

CONTACT

[email protected]

1-800-905-0324

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).
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

Treatment and study plan

Rezdiffra

Drug

Exposure to at least one dose of Resmetirom.

Primary outcomes

Pregnancy and Infant Outcomes Among Women Exposed to Rezdiffra During Pregnancy and/or Lactation

Time frame: From enrollment through pregnancy and up to 12 months of infant age (participant observational period up to approximately 21 months)

To evaluate pregnancy and infant outcomes among women with NASH exposed to Rezdiffra during pregnancy and/or lactation, including pregnancy outcomes, congenital malformations, and infant growth, development, and safety outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Madrigal Pharmaceuticals

CONTACT

[email protected]

800-905-0324

Sponsors and collaborators

Lead sponsor

Madrigal Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Apr 21, 2026
Registry last updated: Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting