MASH - Metabolic Dysfunction-Associated SteatohepatitisPhase 2NCT07335601
Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH
A Phase 2 study testing Resmetirom in people with MASH - Metabolic Dysfunction-Associated Steatohepatitis, run by Madrigal Pharmaceuticals, Inc. at 17 sites in 2 countries.
Trial summary
A Phase 2 double-blind, randomized, placebo-controlled study to evaluate resmetirom in 2 cohorts of subjects with moderate to advanced fibrosis, consistent with stage F2 and F3 fibrosis, who have undergone liver transplant. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MASH - Metabolic Dysfunction-Associated Steatohepatitis
- What is being tested?
- Resmetirom
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 29 Dec 2025to Mar 2029
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 12 months post-liver transplant at screening and meeting one of the following:
- Cohort 1: Liver transplant for MASH cirrhosis with recurrent hepatic steatosis ≥8% by MRI-PDFF
- Cohort 2: Liver transplant for non-MASH etiology with de novo hepatic steatosis ≥8% by MRI-PDFF
- Presence of at least one metabolic risk factor, including overweight/obesity, dysglycemia or type 2 diabetes, hypertension or antihypertensive treatment, hypertriglyceridemia or low HDL cholesterol, or lipid-lowering therapy.
- MASH with moderate to advanced liver fibrosis (F2-F3), confirmed by noninvasive fibrosis assessment (FibroScan and/or MRE) and a liver biopsy consistent with Stage F2/F3 MASH and no evidence of other liver pathology or graft rejection.
- Stable renal function with estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² prior to and during screening.
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- Stable liver enzymes at screening, without clinically significant worsening compared with recent historical values.
- Stable immunosuppressive regimen for at least 3 months prior to screening.
- Females of childbearing potential must have a negative pregnancy test, not be breastfeeding, and agree to use effective contraception during the study and for at least 30 days after the last dose; females not of childbearing potential are eligible.
Who cannot join
- Participation in another interventional clinical trial with investigational drug exposure within 30 days (or 5 half-lives, whichever is longer) prior to screening.
- Phosphatidylethanol (PEth) value of ≥20 ng/mL measured at screening or clinically significant alcohol use within 1 year prior to screening.
- FibroScan VCTE >20 kPa, a baseline biopsy demonstrating fibrosis consistent with F4, or MRE > 5 kPa.
- Uncontrolled or clinically significant thyroid disease, including active hyperthyroidism or untreated hypothyroidism.
- Evidence of active liver disease other than MASH.
- History of liver transplantation for an inborn error of metabolism.
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- Evidence of hepatic impairment or decompensation at screening.
- Steroid resistant rejection of the transplanted liver or kidney, or a history of a rejection treated with high dose steroid within 3 months of screening.
- Chronic rejection or chronic plasma-cell hepatitis.
- Significant post-transplant vascular or biliary complications.
- Significant cardiovascular or cerebrovascular disease within 6 months prior to randomization.
- Uncontrolled hypertension at screening or randomization.
- Current hepatocellular carcinoma.
- Known human immunodeficiency virus (HIV) infection or other clinically significant immunocompromised state.
- Any serious medical condition with a life expectancy of less than 5 years.
- Current substance abuse or drug addiction.
- Significant psychiatric, cognitive, or social conditions that would interfere with study participation or compliance, in the Investigator's judgment.
- Known hypersensitivity to study drug or any of its excipients.
- Use of prohibited concomitant medications that may affect liver function, steatosis, thyroid function, or study outcomes, or unstable doses of allowed metabolic therapies prior to randomization.
- Use of statins above protocol-allowed doses or unstable lipid-lowering therapy prior to randomization.
- Contraindications to MRI, including implanted devices incompatible with MRI, severe claustrophobia, or inability to undergo MRI procedures.
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 2 countries
United States16 sites, 16 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22903
- Recruiting
Northwestern University
Chicago, Illinois, 60208
Cheung, PI, 312-694-1293, k-sipich@northwestern.edu
- Not yet recruiting
The University of Chicago Medicine
Chicago, Illinois, 60637
- Recruiting
Dallas Methodist
Dallas, Texas, 75203
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
- Recruiting
University of California San Diego
La Jolla, California, 92037
- Not yet recruiting
University of California Los Angeles Medical Center
Los Angeles, California, 90095
- Recruiting
Northwell Health Inc, Center for Liver Disease and Transplantation
Manhasset, New York, 11030
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
- Recruiting
Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee, 37212
- Recruiting
NY Presbyterian- Weill Cornell Medicine
New York, New York, 10065
- Not yet recruiting
University of Nebraska
Omaha, Nebraska, 68198-2000
402-559-4000, ccarney@unmc.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
- Not yet recruiting
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
(202) 444-2000, coleman.i.smith@gunet.georgetown.edu
Canada1 site, 1 recruiting
- Not yet recruiting
University Health Network - Toronto General Hospital (TGH)
Toronto, Ontario, M5G 2C4
About this study
Official title: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate MGL-3196 (Resmetirom) in Patients With MASH Who Have Undergone Liver Transplant for MASH Cirrhosis or Other Etiologies
A Phase 2 double-blind, randomized, placebo-controlled study to evaluate resmetirom in 2 cohorts of subjects with moderate to advanced fibrosis, consistent with stage F2 and F3 fibrosis, who have undergone liver transplant. Cohort 1 will consist of patients who have undergone liver transplant for MASH cirrhosis who developed recurrent MASH. Cohort 2 will consist of subjects who have undergone liver transplant for indications other than MASH cirrhosis who developed de novo MASH.
- Being tested
- Resmetirom, Placebo
- Keywords
- Post-Liver Transplant, Cirrhosis, Metabolic dysfunction-associated steatohepatitis (MASH), MASLD, MASH, Liver
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResmetiromDrug
Randomized 80 or 100 mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Resmetirom 80 or 100 mg daily - Cohort 1 | Active comparator | Not described Receives: Drug: Resmetirom |
| Arm 2: Resmetirom 80 or 100 mg daily - Cohort 2 | Active comparator | Not described Receives: Drug: Resmetirom |
| Arm 3: Placebo - Cohort 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 4: Placebo - Cohort 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in liver fat content (LFC) as assessed by MRI-PDFF at Week 28
To determine the effect of MGL-3196/Resmetirom versus matching placebo on percent change from Baseline to Week 28 in hepatic fat fraction by magnetic resonance imaging proton density fat fraction (MRI-PDFF) in patients with baseline MRI-PDFF ≥8%.
Measured: 28 weeks
Secondary outcomes (4)
To evaluate the safety and tolerability of once-daily, oral administration of MGL-3196/resmetirom versus matching placebo in patients who have undergone a liver transplant
Measured: 52 weeks
1.To determine the effect of MGL-3196/resmetirom versus matching placebo on liver stiffness as measured by FibroScan vibration controlled transient elastography (VCTE; kPa)
Absolute change and percent change from Baseline to Week 28 and Week 52 on FibroScan VCTE
Measured: 28 and 52 Weeks
2. To determine the effect of MGL-3196/resmetirom versus matching placebo on serum lipid parameters
Absolute and percent change from Baseline to Week 28 and Week 52 in LDL-C, lipoprotein A [Lp(a)] in patients with baseline Lp(a) >10 nmol/L and triglycerides (TGs) in patients with baseline TGs >150 mg/dL
Measured: 28 and 52 Weeks
3. To determine the effect of MGL-3196/resmetirom versus matching placebo on liver biochemistries
Absolute and percent change from baseline in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and gamma glutamyl transferase (GGT), at Week 28 and Week 52
Measured: 28 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start29 Dec 2025
- Primary completionAug 2028 (estimated)
- Study completionMar 2029 (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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized matching placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Hare, MS, Study director, Madrigal Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335601
- Sponsor's protocol ID
- MGL-3196-27
- Status last verified
- Aug 2026
- First submitted
- 7 Jan 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate MGL-3196 (Resmetirom) in Patients With MASH Who Have Undergone Liver Transplant for MASH Cirrhosis or Other Etiologies
- ClinicalTrials.gov ID
- NCT07335601
- Acronym / sponsor ID
- MGL-3196-27
- Keywords
- Post-Liver Transplant, Cirrhosis, Metabolic dysfunction-associated steatohepatitis (MASH), MASLD, MASH, Liver
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 13 Jan 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.
A Phase 2 double-blind, randomized, placebo-controlled study to evaluate resmetirom in 2 cohorts of subjects with moderate to advanced fibrosis, consistent with stage F2 and F3 fibrosis, who have undergone liver transplant. Cohort 1 will consist of patients who have undergone liver transplant for MASH cirrhosis who developed recurrent MASH. Cohort 2 will consist of subjects who have undergone liver transplant for indications other than MASH cirrhosis who developed de novo MASH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Randomized matching placebo
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Resmetirom 80 or 100 mg daily - Cohort 1 | Active comparator | Drug: Resmetirom |
| Arm 2: Resmetirom 80 or 100 mg daily - Cohort 2 | Active comparator | Drug: Resmetirom |
| Arm 3: Placebo - Cohort 1 | Placebo comparator | Drug: Placebo |
| Arm 4: Placebo - Cohort 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 12 months post-liver transplant at screening and meeting one of the following:
- Presence of at least one metabolic risk factor, including overweight/obesity, dysglycemia or type 2 diabetes, hypertension or antihypertensive treatment, hypertriglyceridemia or low HDL cholesterol, or lipid-lowering therapy.
- MASH with moderate to advanced liver fibrosis (F2-F3), confirmed by noninvasive fibrosis assessment (FibroScan and/or MRE) and a liver biopsy consistent with Stage F2/F3 MASH and no evidence of other liver pathology or graft rejection.
- Stable renal function with estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² prior to and during screening.
- Stable liver enzymes at screening, without clinically significant worsening compared with recent historical values.
Key exclusion criteria (21 listed)
- Participation in another interventional clinical trial with investigational drug exposure within 30 days (or 5 half-lives, whichever is longer) prior to screening.
- Phosphatidylethanol (PEth) value of ≥20 ng/mL measured at screening or clinically significant alcohol use within 1 year prior to screening.
- FibroScan VCTE >20 kPa, a baseline biopsy demonstrating fibrosis consistent with F4, or MRE > 5 kPa.
- Uncontrolled or clinically significant thyroid disease, including active hyperthyroidism or untreated hypothyroidism.
- Evidence of active liver disease other than MASH.
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 |
|---|---|---|
| ResmetiromRandomized 80 or 100 mg | Drug | Arm 1: Resmetirom 80 or 100 mg daily - Cohort 1, Arm 2: Resmetirom 80 or 100 mg daily - Cohort 2 |
| PlaceboPlacebo | Drug | Arm 3: Placebo - Cohort 1, Arm 4: Placebo - Cohort 2 |
Primary outcome
Percent change from baseline in liver fat content (LFC) as assessed by MRI-PDFF at Week 28
Time frame: 28 weeks
To determine the effect of MGL-3196/Resmetirom versus matching placebo on percent change from Baseline to Week 28 in hepatic fat fraction by magnetic resonance imaging proton density fat fraction (MRI-PDFF) in patients with baseline MRI-PDFF ≥8%.
4 secondary outcomes
To evaluate the safety and tolerability of once-daily, oral administration of MGL-3196/resmetirom versus matching placebo in patients who have undergone a liver transplant
Time frame: 52 weeks
1.To determine the effect of MGL-3196/resmetirom versus matching placebo on liver stiffness as measured by FibroScan vibration controlled transient elastography (VCTE; kPa)
Time frame: 28 and 52 Weeks
2. To determine the effect of MGL-3196/resmetirom versus matching placebo on serum lipid parameters
Time frame: 28 and 52 Weeks
3. To determine the effect of MGL-3196/resmetirom versus matching placebo on liver biochemistries
Time frame: 28 and 52 weeks
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 26 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Tom Hare, MS study director
Madrigal Pharmaceuticals, Inc.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resmetirom in people with MASH - Metabolic Dysfunction-Associated Steatohepatitis, run by Madrigal Pharmaceuticals, Inc. at 17 sites in 2 countries.
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 9 inclusion and 21 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 David Hernandez, MD (302-640-2217, dhernandez@madrigalpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in liver fat content (LFC) as assessed by MRI-PDFF at Week 28 (time frame: 28 weeks). 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 26 Aug 2026.