Rezdiffra Pregnancy and Lactation Registry
This study is a registry for women who have been exposed to Rezdiffra (resmetirom) during pregnancy or while breastfeeding. Rezdiffra is a medication for MASH (Metabolic Dysfunction-Associated Steatohepatitis), a type of liver disease. The registry aims to collect information about how Rezdiffra affects pregnant and breastfeeding women and their babies. You may be able to join if you are a woman with MASH who has used Rezdiffra during pregnancy or while breastfeeding, and your baby is up to 12 months old. The goal is to understand the safety of Rezdiffra for mothers and their infants. The study is currently unclear on its recruitment status.
- Study design
- This is an observational study designed to collect information from about 10 women. It is not a clinical trial where a new treatment is being tested.
- What's involved
- The study will collect information from the time you enroll through your pregnancy and up to 12 months after your baby is born, for a total of about 21 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from enrollment through pregnancy and up to 12 months of infant age, for an observational period of up to approximately 21 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Rezdiffra Pregnancy and Lactation Registry
At a glance
Conditions
NCT07541469
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Madrigal Pharmaceuticals
West Conshohocken, Pennsylvaniastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Pregnancy and Infant Outcomes Among Women Exposed to Rezdiffra During Pregnancy and/or LactationFrom enrollment through pregnancy and up to 12 months of infant age (participant observational period up to approximately 21 months)
To evaluate pregnancy and infant outcomes among women with NASH exposed to Rezdiffra during pregnancy and/or lactation, including pregnancy outcomes, congenital malformations, and infant growth, development, and safety outcomes.