NCT07541469 Rezdiffra Pregnancy and Lactation Registry
| NCT ID | NCT07541469 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Madrigal Pharmaceuticals, Inc. |
| Condition | MASH - Metabolic Dysfunction-Associated Steatohepatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-03-04 |
| Primary Completion | 2030-04-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10 participants in total. It began in 2026-03-04 with a primary completion date of 2030-04-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07541469 clinical trial?
This trial is open to female participants only, studying MASH - Metabolic Dysfunction-Associated Steatohepatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07541469 currently recruiting?
Yes, NCT07541469 is actively recruiting participants. Contact the research team at MHGSafety@iconplc.com for enrollment information.
Where is the NCT07541469 trial being conducted?
This trial is being conducted at West Conshohocken, United States.
Who is sponsoring the NCT07541469 clinical trial?
NCT07541469 is sponsored by Madrigal Pharmaceuticals, Inc.. The trial plans to enroll 10 participants.