700 Participants Needed

Resmetirom for NASH Cirrhosis

Recruiting at 54 trial locations
TH
Overseen ByThomas Hare
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Madrigal Pharmaceuticals, Inc.
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Resmetirom for NASH Cirrhosis?

Research shows that Resmetirom, a drug targeting liver cells, can reduce liver fat and improve liver health in patients with non-alcoholic steatohepatitis (NASH), a condition similar to NASH cirrhosis. It has been shown to decrease liver fat, improve cholesterol levels, and reduce liver stiffness, indicating its potential effectiveness for liver-related conditions.12345

What makes the drug Resmetirom unique for treating NASH cirrhosis?

Resmetirom is unique because it is an orally administered drug that specifically targets the liver and works by activating thyroid hormone receptor-β, which helps increase fat metabolism and reduce liver fat and inflammation. This targeted approach is different from other treatments that may not focus specifically on the liver or use this mechanism.12345

What is the purpose of this trial?

This trial tests a daily pill called resmetirom for people with a stable form of liver disease not caused by alcohol. The goal is to see if the drug can improve liver function and reduce liver fat, thereby preventing serious complications. Resmetirom has been tested in previous studies for the treatment of liver disease.

Research Team

TH

Thomas Hare

Principal Investigator

VP, Clinical Research

Eligibility Criteria

This trial is for adults with well-compensated NASH cirrhosis, confirmed by biopsy or MRI-PDFF. They should have a Child-Pugh A score and no history of hepatic decompensation. Participants must not have other chronic liver diseases or a MELD score ≥12.

Inclusion Criteria

Enhanced liver function (ELF) ≥9.8, only if MRE is unavailable or contraindicated.
My latest liver biopsy shows significant damage and fat.
I have a history of NASH with significant fibrosis, now with cirrhosis.
See 6 more

Exclusion Criteria

I do not have any liver conditions other than NASH cirrhosis.
I have never had liver failure or serious liver problems.
Participants with MELD score ≥12 due to liver disease are excluded.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

Treatment

Participants receive 80 mg resmetirom or matching placebo daily until the required number of Composite Clinical Outcome events are achieved

Approximately 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Placebo
  • Resmetirom
Trial Overview The study tests if taking Resmetirom (80 mg daily) affects the time until patients with NASH cirrhosis experience significant health events compared to a placebo group. It's an oral medication given once per day.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: ResmetiromActive Control1 Intervention
80 mg daily
Group II: PlaceboPlacebo Group2 Interventions
matching placebo daily

Resmetirom is already approved in United States for the following indications:

🇺🇸
Approved in United States as Rezdiffra for:
  • Noncirrhotic nonalcoholic steatohepatitis with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Madrigal Pharmaceuticals, Inc.

Lead Sponsor

Trials
16
Recruited
5,400+

Findings from Research

In a 36-week study involving 125 patients with biopsy-confirmed NASH, resmetirom significantly reduced hepatic fat compared to placebo, with a 32.9% reduction at 12 weeks and 37.3% at 36 weeks, indicating its efficacy in treating NASH.
The treatment was generally safe, with most adverse events being mild or moderate; however, there was a higher incidence of mild diarrhea and nausea in patients taking resmetirom.
Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.Harrison, SA., Bashir, MR., Guy, CD., et al.[2021]
Resmetirom (MGL-3196) is a promising treatment for nonalcoholic steatohepatitis (NASH) that has shown potential cost-effectiveness, with an incremental cost-effectiveness ratio of $53,929 per quality-adjusted life-year (QALY) gained, based on a model informed by a phase II clinical trial.
The use of resmetirom could significantly reduce serious liver-related complications, such as decompensated cirrhosis, hepatocellular carcinoma, and the need for liver transplants, indicating its efficacy in improving long-term health outcomes for patients with NASH.
Early Cost-Effectiveness and Price Threshold Analyses of Resmetirom: An Investigational Treatment for Management of Nonalcoholic Steatohepatitis.Javanbakht, M., Fishman, J., Moloney, E., et al.[2023]
In a 52-week phase 3 trial involving 1,143 adults with presumed NASH, resmetirom was found to be safe and well tolerated, with treatment-emergent adverse events occurring in similar rates compared to placebo.
Resmetirom significantly reduced hepatic fat, LDL-C, apoB, and triglycerides, indicating its potential efficacy in treating nonalcoholic steatohepatitis and supporting further clinical development.
Resmetirom for nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled phase 3 trial.Harrison, SA., Taub, R., Neff, GW., et al.[2023]

References

Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. [2021]
Early Cost-Effectiveness and Price Threshold Analyses of Resmetirom: An Investigational Treatment for Management of Nonalcoholic Steatohepatitis. [2023]
Resmetirom for nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled phase 3 trial. [2023]
Resmetirom Ameliorates NASH-Model Mice by Suppressing STAT3 and NF-κB Signaling Pathways in an RGS5-Dependent Manner. [2023]
Effects of Resmetirom on Noninvasive Endpoints in a 36-Week Phase 2 Active Treatment Extension Study in Patients With NASH. [2023]
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