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Rezdiffra Pregnancy and Lactation Registry

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

Who can join

All ages · Women · Healthy volunteers welcome

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

About the study

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.

What is being tested

• Rezdiffra (drug)

Sponsor: Madrigal Pharmaceuticals, Inc. · Participants: 10 · Started: Mar 4, 2026

Contact the study team

• Madrigal Pharmaceuticals · Phone: 800-905-0324

Official record on ClinicalTrials.gov — NCT07541469

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.