Rezdiffra Pregnancy and Lactation Registry

NCT07541469 | Recruiting FDA Drug

• 1 other identifier: MGL-3196-25
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Pregnancy and Infant Outcomes Among Women Exposed to Rezdiffra During Pregnancy and/or Lactation

  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.

  From enrollment through pregnancy and up to 12 months of infant age (participant observational period up to approximately 21 months)

Interventions

Rezdiffra DRUG

Exposure to at least one dose of Resmetirom.

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The registry will allow healthcare providers (HCPs) to enroll eligible patients and will also allow eligible patients to self-enroll. The registry is voluntary.

You may qualify if:

• 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.

You may not qualify if:

• NONE

Sponsors & Collaborators

• Madrigal Pharmaceuticals, Inc.: lead

Study Sites (1)

Madrigal Pharmaceuticals

West Conshohocken, Pennsylvania, 19428, United States

RECRUITING

Related Links

• The Rezdiffra Pregnancy and Lactation Registry

Central Study Contacts

Madrigal Pharmaceuticals

CONTACT

800-905-0324; MHGSafety@iconplc.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 21 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 21, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): April 8, 2030
• Study Completion (Estimated): April 8, 2030
• Last Updated: April 21, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)