Non-alcoholic steatohepatitis, or NASH, is liver inflammation and damage caused by fat buildup in people who drink little or no alcohol. It affects roughly 5% of US adults and can progress to cirrhosis and liver failure. Until 2024, no medications were approved specifically for NASH, though diabetes and weight-loss drugs often help.
What's actually going on in research
Trials are testing drugs that target different pathways: GLP-1 receptor agonists like semaglutide that reduce liver fat through weight loss, thyroid hormone receptor-beta agonists that directly reduce fat and fibrosis, FGF21 analogs, and drugs that block specific inflammatory signals. Many studies now require liver biopsy to confirm NASH and measure fibrosis, the scarring that predicts who will develop cirrhosis.
GLP-1 receptor agonists
Semaglutide and tirzepatide, approved for diabetes and obesity, are being tested specifically for NASH. They produce significant weight loss, which reduces liver fat and inflammation in many people.
Thyroid hormone receptor-beta agonists
Resmetirom received FDA approval in 2024 for NASH with moderate to advanced fibrosis, the first approved NASH drug. It works directly in the liver to reduce fat and may slow fibrosis progression.
Fibrosis reversal
Several trials are testing whether drugs can actually reverse liver scarring, not just stop it from worsening. This would change outcomes for people already at risk of cirrhosis.
What to know before you search
Eligibility typically depends on biopsy-confirmed NASH, fibrosis stage, liver enzyme levels, and absence of other liver diseases or heavy alcohol use.
What types of trials are currently open
- Treatment trials — Testing drugs to reduce liver fat, inflammation, and fibrosis. Most require liver biopsy at the start and after 12-18 months to measure changes.
- Weight-loss drug trials — Testing GLP-1 drugs and other weight-loss medications to see if metabolic improvement translates to liver benefit in NASH.
- Combination trials — Testing two or more drugs together, targeting different pathways, to see if combination therapy works better than single drugs.
- Biomarker studies — Looking for blood tests or imaging that could replace liver biopsy for diagnosing NASH and tracking treatment response.
- Prevention trials — Testing whether drugs can prevent progression from simple fatty liver to NASH in people at high risk.
Recently added Non-alcoholic Steatohepatitis trials
High-Plant-Protein-Diet or High-Animal-Protein-Diet for Improving Alcoholic Fatty Liver Disease
Alcohol-associated liver disease (ALD) is a major cause of mortality from advanced liver disease, accounting for 47.9% of cirrhosis-related deaths and 30% of hepatocellular carcinoma-related deaths annually. In China, both per capita alcohol consumption and the prevalence of ALD (approximately 5.15%) are on the rise, making ALD an increasingly significant public health burden. Alcohol-associated fatty liver disease (AFLD), the initial and most reversible stage of ALD, is pathologically characterized by excessive hepatic lipid accumulation, mild hepatocellular injury, and low-grade inflammation. It can progress to alcoholic hepatitis, and in some patients, advance to hepatic fibrosis, cirrhosis, or even hepatocellular carcinoma. Currently, there is no established effective pharmacotherapy for AFLD; although alcohol abstinence remains the optimal strategy for disease reversal, sustained abstinence is often difficult to achieve among individuals with alcohol dependence. Dietary protein source may independently influence metabolic health beyond total protein intake. Plant proteins (primarily derived from legumes and cereals) are rich in arginine, glutamine, and fiber-associated bioactive compounds, whereas animal proteins (mainly from dairy and poultry) are abundant in branched-chain amino acids (BCAAs) and sulfur-containing amino acids. Preclinical studies have demonstrated that, compared with animal proteins such as casein, plant proteins more effectively attenuate high-fat- or alcohol-induced hepatic steatosis by upregulating hepatic PPAR-α expression and suppressing SREBP-1c activity. Human intervention studies further suggest that long-term higher intake of plant protein is associated with lower hepatic fat content and reduced risk of insulin resistance. However, no randomized controlled trial has yet directly compared the effects of high-purity plant protein versus animal protein supplementation on clinical outcomes in patients with AFLD under isocaloric and isonitrogenous conditions. Therefore, this study aims to conduct a randomized controlled trial to evaluate the effects of plant protein versus animal protein supplementation within an isocaloric dietary framework on liver function, hepatic fat content, and glucose-lipid metabolism in individuals with AFLD. The findings will elucidate the efficacy and underlying mechanisms of protein-source modulation in ameliorating AFLD, thereby providing population-based evidence and strategic guidance for health promotion in this patient population.
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called metabolic dysfunction-associated steatohepatitis (MASH). MASH is more advanced stage of a broader liver disease, MASLD. MASLD is a liver condition caused by too much fat building up in the liver. This can lead to liver scarring and inflammation and can reduce the liver's ability to keep the body healthy. Cell death-inducing DFFA-like effector B (CIDEB) is a protein made by liver cells that helps the liver to store fat. The study is looking at: * What side effects ALN-CIDEB might cause * How well ALN-CIDEB works to change liver fat, liver injury, and liver scarring * How ALN-CIDEB could affect the body and the liver, which can help researchers understand why ALN-CIDEB works better for some people than others
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