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

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.