Resmetirom for Fatty Liver Disease Post-Liver Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests resmetirom, a treatment for fatty liver disease that can develop after a liver transplant. It aims to evaluate resmetirom's effectiveness in individuals with moderate to advanced liver scarring (fibrosis) and fatty liver issues, either recurring after a transplant for MASH cirrhosis or emerging after other types of liver transplants. The trial includes different groups, with some receiving resmetirom and others a placebo (a pill with no active medicine), to compare outcomes. Candidates may qualify if they have had a liver transplant, have liver scarring, and face metabolic issues like being overweight or having type 2 diabetes. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it mentions that you must have a stable immunosuppressive regimen and stable doses of allowed metabolic therapies before joining. Some medications that affect liver or thyroid function might be prohibited.
Is there any evidence suggesting that resmetirom is likely to be safe for humans?
Research has shown that resmetirom is generally safe and well-tolerated. In studies, adults with NASH, a type of fatty liver disease, experienced few issues with the treatment. Most reported mild side effects, such as an upset stomach or headache, but these were not serious. The FDA has already approved resmetirom for treating MASH, a liver disease similar to NASH, indicating that experts believe the drug's benefits outweigh the risks for that condition. While ongoing research continues, current evidence suggests resmetirom is a promising and safe option for liver health.12345
Why do researchers think this study treatment might be promising for fatty liver disease?
Resmetirom is unique because it targets a specific thyroid hormone receptor, which plays a vital role in regulating liver fat metabolism. Unlike current treatments for fatty liver disease, such as lifestyle changes or off-label medications, Resmetirom directly reduces liver fat with potentially fewer side effects. Researchers are excited about its potential to improve liver health post-transplant by addressing the root cause of fat accumulation more effectively than existing options.
What evidence suggests that resmetirom might be an effective treatment for fatty liver disease post-liver transplant?
Research has shown that resmetirom may help treat liver conditions. In one study, 25.9% of patients taking 80 mg and 29.9% taking 100 mg of resmetirom improved their NASH (a type of fatty liver disease) without worsening liver scarring. Another study found that after two years, patients on resmetirom had less liver stiffness, indicating better liver health. Resmetirom targets thyroid hormone receptors, reducing liver fat and inflammation. Overall, early evidence suggests resmetirom might effectively improve liver conditions like MASH. Participants in this trial will receive either resmetirom at 80 or 100 mg daily or a placebo to further evaluate its effectiveness post-liver transplant.45678
Who Is on the Research Team?
Tom Hare, MS
Principal Investigator
Madrigal Pharmaceuticals, Inc.
Are You a Good Fit for This Trial?
This trial is for post-liver transplant patients with MASH-related fibrosis. Cohort 1 includes those who had a transplant due to MASH cirrhosis and have recurrent MASH, while Cohort 2 includes those transplanted for other reasons but developed new-onset MASH. Participants must have stable kidney function, liver enzymes, and immunosuppressive regimens; agree to use contraception if of childbearing potential; and not be pregnant or breastfeeding.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Resmetirom or placebo daily for 28 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue to be monitored for long-term effects up to 52 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Resmetirom
Trial Overview
The study tests Resmetirom against a placebo in two groups of liver transplant recipients with moderate to advanced fibrosis from MASH. It's double-blind (neither doctors nor patients know who gets what), randomized (assigned by chance), and placebo-controlled (compared with an inactive substance).
How Is the Trial Designed?
4
Treatment groups
Active Control
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Madrigal Pharmaceuticals, Inc.
Lead Sponsor
Citations
A Phase 3, Randomized, Controlled Trial of Resmetirom in ...
NASH resolution with no worsening of fibrosis was achieved in 25.9% of the patients in the 80-mg resmetirom group and 29.9% of those in the 100- ...
2.
ir.madrigalpharma.com
ir.madrigalpharma.com/news-releases/news-release-details/madrigal-announces-new-two-year-data-compensated-mash-cirrhosisMadrigal Announces New Two-Year Data from the ...
Mean liver stiffness at baseline was 25 kPa and patients achieved a mean 6.7 kPa reduction in liver stiffness at two years (6.1 kPa at one year) ...
Resmetirom for MASH: A Comprehensive Review of a Novel ...
Resmetirom improved the NAFLD activity score (NAS) by decreasing steatosis and inflammation [38]. 4.2. Mechanism of Action of Resmetirom.
Resmetirom for nonalcoholic fatty liver disease
TEAEs occurred in 86.5% (open-label 100 mg resmetirom), 86.1% (100 mg resmetirom), 88.4% (80 mg resmetirom) and 81.8% (placebo) of patients.
Resmetirom for nonalcoholic steatohepatitis
Resmetirom is a once-daily oral drug being investigated for the treatment of NASH with fibrosis. It is a thyroid hormone receptor β agonist that acts by ...
Efficacy and safety of resmetirom among patients with non ...
Resmetirom holds potential as a therapeutic option for NASH patients, pending further clinical validation. Non-alcoholic fatty liver disease ( ...
Resmetirom and Obeticholic Acid for Non-Alcoholic ...
1 Patients with NASH may have liver fibrosis, and liver fibrosis can progress to cirrhosis placing patients at high risk of death from liver ...
a review of efficacy and safety data from clinical trials | The ...
Resmetirom is a recently approved FDA drug for MASH. It targets multiple pathways involved in the disease, including fat metabolism, ...
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