Recruiting

Rezdiffra

Sponsor:

Madrigal Pharmaceuticals, Inc.

Code:

NCT07541469

Conditions

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Rezdiffra

Study Details

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

Study ID

NCT07541469

Start date

Mar 4, 2026

Status verified date

Mar, 2026

Completion date

Apr 8, 2030

Anticipated

Primary completion date

Apr 8, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 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).
2. 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

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Interventions

Rezdiffra

Exposure to at least one dose of Resmetirom.

Primary outcome measure

  • Pregnancy and Infant Outcomes Among Women Exposed to Rezdiffra During Pregnancy and/or Lactation [ Time Frame: From enrollment through pregnancy and up to 12 months of infant age (participant observational period up to approximately 21 months) ]

Central Contacts and Locations

Central contacts

Madrigal Pharmaceuticals

800-905-0324MHGSafety@iconplc.com

Locations

Madrigal Pharmaceuticals

Recruiting

West Conshohocken, Pennsylvania, United States, 19428

Contacts

Event Reporting Desk

1-800-905-0324MHGSafety@iconplc.com

More Information

Sponsor

Madrigal Pharmaceuticals, Inc.

Last update posted

Apr 21, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Madrigal Pharmaceuticals, Inc. on 2026-04-21.