RecruitingNot Applicable

Rezdiffra Pregnancy and Lactation Registry

United States10 participantsStarted 2026-03-04

Plain-language 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.

Who can participate

SexFEMALE

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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.

What they're measuring

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

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

Trial details

NCT IDNCT07541469

SponsorMadrigal Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-04-08

Contact for this trial

Madrigal Pharmaceuticals

800-905-0324 MHGSafety@iconplc.com

View on ClinicalTrials.gov More MASH - Metabolic Dysfunction-Associated Steatohepatitis trials