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Rezdiffra Pregnancy and Lactation Registry

Madrigal Pharmaceuticals, Inc. · NCT07541469

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Any age listed · Women only
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
10
US sites recruiting
1
Study start
March 4, 2026
Record last updated
April 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Rezdiffra

Conditions: MASH - Metabolic Dysfunction-Associated Steatohepatitis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

NONE

Recruiting US locations

  • Madrigal Pharmaceuticals

    West Conshohocken, PA 19428

    Site contact: Event Reporting Desk · 1-800-905-0324 · MHGSafety@iconplc.com

Study contacts (from the official record)

  • Madrigal Pharmaceuticals · 800-905-0324 · MHGSafety@iconplc.com
Rezdiffra Pregnancy and Lactation Registry (NCT07541469) | Bored Studies