NCT07541469Recruiting
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
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10 (estimated)
- First submitted
- 19 Mar 2026
- Start date
- 4 Mar 2026
- Primary completion date
- 8 Apr 2030
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07541469
What you commit to
- Study type: Observational
- Planned participants: 10
- From 4 Mar 2026 to the primary completion date, 8 Apr 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- NONE
Who the study is looking for
- 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.
Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Madrigal Pharmaceuticals Coordinator of this site? Confirm its status | West Conshohocken | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.