Rezdiffra Pregnancy and Lactation Registry

NCT07541469 · tracked via the Priya Life Science USA tracker

Sponsor

Madrigal Pharmaceuticals, Inc.

Phase

Observational

Started

2026-03-04

Last updated

2026-04-21

Condition(s) studied

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Investigational drug(s) / intervention(s)

Rezdiffra

Rezdiffra: Exposure to at least one dose of Resmetirom.

Study 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.

Eligibility

Sex

FEMALE

Min age

—

Max age

—

Healthy volunteers

Accepted

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

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Madrigal Pharmaceuticals	West Conshohocken	Pennsylvania	Recruiting

More Madrigal Pharmaceuticals, Inc. trials in the USA

A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis Active, not recruiting

Study of Resmetirom in Children and Adolescents With MASH Recruiting

A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES) Active, not recruiting

Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH Recruiting

A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE) Active, not recruiting

Other trials for the same condition

A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH Recruiting

A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH) Recruiting

Study of Resmetirom in Children and Adolescents With MASH Recruiting

Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07541469 on ClinicalTrials.gov ↗ ← All trials in the USA