Rezdiffra Pregnancy and Lactation Registry

April 14, 2026 updated by: Madrigal Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • West Conshohocken, Pennsylvania, United States, 19428
        • Recruiting
        • Madrigal Pharmaceuticals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The registry will allow healthcare providers (HCPs) to enroll eligible patients and will also allow eligible patients to self-enroll. The registry is voluntary.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment through pregnancy and up to 12 months of infant age (participant observational period up to approximately 21 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Madrigal Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2026

Primary Completion (Estimated)

April 8, 2030

Study Completion (Estimated)

April 8, 2030

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • MGL-3196-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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