What is a clinical trial?

A clinical trial is a research study involving human participants designed to evaluate medical interventions — such as drugs, devices, or behavioral strategies. Trials follow a structured protocol and are registered on ClinicalTrials.gov. They progress through phases: Phase 1 (safety), Phase 2 (efficacy), Phase 3 (large-scale comparison), and Phase 4 (post-market surveillance).

How do I find clinical trials I'm eligible for?

You can search ClinicalTrials.gov or use ClinicalMetric to filter by condition, phase, or location. Each trial listing includes eligibility criteria such as age range, sex, diagnosis, and prior treatment history. Contact the study team directly or ask your physician to refer you to a relevant trial.

Are clinical trials safe to participate in?

Clinical trials are conducted under strict ethical and regulatory oversight, including IRB approval and FDA regulation in the US. All participants must give informed consent after reviewing potential risks and benefits. Phase 1 trials carry more uncertainty, while Phase 3 trials involve interventions with an established safety profile. Participation is always voluntary and you may withdraw at any time.

What are the phases of clinical trials?

Clinical trials progress through four main phases. Phase 1 tests safety and dosing in a small group (20–80 people). Phase 2 evaluates efficacy and side effects in a larger group (100–300). Phase 3 compares the intervention against standard treatments in thousands of participants. Phase 4 occurs after approval and monitors long-term effects in the general population.

Do participants get paid for joining clinical trials?

Many clinical trials offer compensation for time and travel expenses, though payment structures vary widely by study. Compensation is not intended to be coercive. Some trials also cover treatment costs for participants. Always review the consent form carefully and ask the study coordinator about any financial considerations before enrolling.

Liver Disease Clinical Trials 2026: MASH, Cirrhosis & Hepatitis B Cure

Medical Notice

This article is for informational purposes only and does not constitute medical advice. Clinical trial eligibility and availability vary. Always consult a qualified healthcare professional before making any medical decisions or considering participation in a clinical trial.

Summary

Liver disease research has entered a historic phase. Resmetirom (Rezdiffra) became the first FDA-approved drug for metabolic-associated steatohepatitis (MASH, formerly NASH) in March 2024. The MASH pipeline now has over 30 drugs in Phase 2/3 trials. Separately, functional cure of hepatitis B — long considered impossible — is being approached through novel RNA interference and capsid assembly modulator combinations. This guide explains the active trial landscape.

MASH (Metabolic-Associated Steatohepatitis) Trials

MASH affects approximately 6% of the global population and is projected to become the leading cause of liver transplantation. Following resmetirom's approval, the pipeline is crowded with drugs targeting different mechanisms:

Semaglutide for MASH: ESSENCE trial Phase 3 results (2024) showed semaglutide 2.4mg reduced MASH resolution and fibrosis improvement — pending FDA approval for MASH indication
Lanifibranor (pan-PPAR agonist): Phase 3 NATIVE trial showed improvement in MASH and fibrosis — under regulatory review
Efruxifermin (FGF21 analog): Phase 3 SYNCHRONY trial for MASH with fibrosis F2–F3 actively recruiting
Combination trials: GLP-1 + FXR agonist, GLP-1 + FGF21 combinations are being tested for additive fibrosis reversal

Cirrhosis Trials

Advanced fibrosis (F3) and cirrhosis (F4) have historically been considered irreversible. Emerging data from multiple trials show that fibrosis regression is possible with effective MASH treatment. Specific cirrhosis trials are testing drugs that directly target activated hepatic stellate cells (the fibrosis-producing cells) — including FGF19 analogs and anti-LOXL2 approaches. Portal hypertension reduction (measured by HVPG) is being used as a surrogate endpoint in cirrhosis trials.

Hepatitis B Functional Cure

Chronic hepatitis B affects 296 million people. Current antivirals (tenofovir, entecavir) suppress viral replication but rarely achieve cure (defined as HBsAg loss). New approaches in Phase 2/3 trials:

RNA interference (RNAi): SiRNA drugs (JNJ-3989, VIR-2218, AB-729) targeting HBV RNA — reducing all viral proteins including HBsAg
Capsid assembly modulators (CAMs): Disrupting HBV core protein assembly — targeting cccDNA reservoir
Combination regimens: RNAi + CAM + nucleoside analog combinations in finite treatment duration trials

Eligibility for Liver Disease Trials

MASH trials require: biopsy-confirmed MASH (NAS ≥4, fibrosis F2–F3 for most trials), elevated liver enzymes or steatosis on imaging, no other causes of liver disease. Cirrhosis trials often require HVPG measurement (invasive) at baseline. Hepatitis B trials require: HBsAg positive ≥6 months, HBV DNA and HBsAg quantification, and typically require patients to be on stable nucleoside analog therapy. Active alcohol use and other chronic liver diseases are standard exclusions.