Actively Recruiting
A Phase 4 Observational Registry to Evaluate Safety in Women With NASH and Their Infants Exposed to Rezdiffra During Pregnancy and Lactation
Led by Madrigal Pharmaceuticals, Inc. · Updated on 2026-04-21
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational registry is designed to collect information on pregnancy and clinical outcomes in women with metabolic dysfunction-associated steatohepatitis (NASH) who have been exposed to Rezdiffra (resmetirom) during pregnancy and/or lactation. The study aims to understand how this medication affects both the women and their infants up to 12 months after birth, providing valuable safety data for healthcare providers worldwide. Participants include women who have taken at least one dose of Rezdiffra around the time of conception, during pregnancy, or while breastfeeding. The registry observes these women and their infants without administering any new treatments or interventions. Data is gathered throughout pregnancy and continues until the infants reach one year of age. During the study, researchers collect detailed information about pregnancy outcomes and infant health through regular follow-ups lasting up to approximately 21 months total, from enrollment through pregnancy and infant age. This includes monitoring clinical outcomes related to the medication exposure, ensuring careful observation of both mother and child during this period.
CONDITIONS
Brief Title
Rezdiffra Pregnancy and Lactation Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with NASH who have been exposed to at least one dose of resmetirom during pregnancy or lactation
- Infants up to 12 months old of these women
- Ability to understand and provide informed consent through an approved form
You will not qualify if you...
- None reported
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Enrollment through pregnancy and up to 12 months of infant age (approximately 21 months total)
Participants who have been exposed to Rezdiffra during pregnancy or lactation are observed along with their infants up to 12 months after birth to collect safety information.
Periodic visits or contacts up to 12 months after delivery
Trial Site Locations
Total: 1 location
1
Madrigal Pharmaceuticals
West Conshohocken, Pennsylvania, United States, 19428
Actively Recruiting
Research Team
M
Madrigal Pharmaceuticals
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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