MASH - Metabolic Dysfunction-Associated SteatohepatitisNCT07541469
Rezdiffra Pregnancy and Lactation Registry
An observational study of MASH - Metabolic Dysfunction-Associated Steatohepatitis, run by Madrigal Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- MASH - Metabolic Dysfunction-Associated Steatohepatitis
- What is being tested?
- Rezdiffra
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2026to 8 Apr 2030
- How long will I take part?
- 21 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- NONE
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Madrigal Pharmaceuticals
West Conshohocken, Pennsylvania, 19428
Event Reporting Desk, 1-800-905-0324, MHGSafety@iconplc.com
About this study
Official title: A Phase 4, Decentralized Observational Registry to Evaluate the Safety in Women With NASH and Their Infants Exposed to REZDIFFRA™ (Resmetirom) During Pregnancy and/or Lactation
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.
Read the detailed description
The purpose of the Rezdiffra™ Pregnancy and Lactation Registry is to create a worldwide information source, called a pregnancy registry. The registry will collect information about the safety of Rezdiffra™ (resmetirom), an approved medication, during pregnancy and/or while breastfeeding. This will help doctors and other healthcare providers learn more about its effect on pregnant and breastfeeding women and their infant after delivery up to 12 months of age.
- Being tested
- Rezdiffra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RezdiffraDrug
Exposure to at least one dose of Resmetirom.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment through pregnancy and up to 12 months of infant age (participant observational period up to approximately 21 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start4 Mar 2026
- Primary completion8 Apr 2030 (estimated)
- Study completion8 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASH - Metabolic Dysfunction-Associated SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 10 participants (estimated)
- Target duration
- 21 Months
Sponsor and investigators
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541469
- Sponsor's protocol ID
- MGL-3196-25
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Decentralized Observational Registry to Evaluate the Safety in Women With NASH and Their Infants Exposed to REZDIFFRA™ (Resmetirom) During Pregnancy and/or Lactation
- ClinicalTrials.gov ID
- NCT07541469
- Acronym / sponsor ID
- MGL-3196-25
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 8 Apr 2030 (estimated)
- Study completion
- 8 Apr 2030 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the Rezdiffra™ Pregnancy and Lactation Registry is to create a worldwide information source, called a pregnancy registry. The registry will collect information about the safety of Rezdiffra™ (resmetirom), an approved medication, during pregnancy and/or while breastfeeding. This will help doctors and other healthcare providers learn more about its effect on pregnant and breastfeeding women and their infant after delivery up to 12 months of age.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 21 Months
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- NONE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RezdiffraExposure to at least one dose of Resmetirom. | Drug | – |
Primary outcome
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- The Rezdiffra Pregnancy and Lactation RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for MASH - Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Recruiting
Exercise for an Aging Liver (EXALIVER)
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Not yet recruitingPhase 2
To Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis
Metabolic Dysfunction-associated Steatohepatitis (MASH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MASH - Metabolic Dysfunction-Associated Steatohepatitis, run by Madrigal Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madrigal Pharmaceuticals (800-905-0324, MHGSafety@iconplc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.