Rezdiffra Pregnancy and Lactation Registry
Recruiting now
Conditions studied: MASH - Metabolic Dysfunction-Associated Steatohepatitis
In brief
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.
Key facts
- Study ID
- NCT07541469
- Run by
- Madrigal Pharmaceuticals, Inc.
- People needed
- 10
- Starts
- 2026-03-04
- Expected to finish
- 2030-04-08
- Last updated by the study team
- 2026-04-21
Who can join
Age: any. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- NONE
Where it is running
- Madrigal Pharmaceuticals — West Conshohocken, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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