Fatty Liver Disease: MASLD (NAFLD) and MASH (NASH) Clinical Trials.
It has no symptoms in the early stages. It affects one in four adults worldwide. And right now, fatty liver disease
clinical research is racing to find the first FDA-approved treatments.
Key Takeaways
- Fatty liver disease, now called MASLD (NAFLD), is a buildup of fat in the liver caused by metabolic problems rather than alcohol (American Liver Foundation).
- MASLD affects about 24% of U.S. adults, an estimated 80–100 million people, and about a quarter to a third of people worldwide (American Liver Foundation).
- MASLD often has no early symptoms and can progress to MASH (NASH), where inflammation and scarring can lead to cirrhosis, liver failure, or liver cancer.
- MASH (NASH) is the leading cause of liver transplants among women and adults 65 and older in the U.S. (American Liver Foundation).
- Adults with elevated liver enzymes or a MASLD (NAFLD) or MASH (NASH) diagnosis may qualify for clinical trials at Mission Research Institute in Gilbert, AZ.
You may have heard your doctor mention an abnormal liver enzyme on a blood test — an elevated ALT or AST — and told you to reduce alcohol intake or lose weight. What your doctor may also be watching carefully is whether that abnormal result is the first sign of a condition called MASLD (NAFLD): Non-Alcoholic Fatty Liver Disease — now the focus of a growing number of fatty liver disease clinical trials.
MASLD (NAFLD) affects an estimated 80–100 million Americans For many, it stays relatively mild. But for a significant subset, it progresses to MASH (NASH) — Metabolic Dysfunction-Associated Steatohepatitis — a more serious form of liver inflammation that can lead to cirrhosis, liver failure, or liver cancer.
What Is the Difference Between MASLD (NAFLD) and MASH (NASH)?
MASLD (NAFLD) is the umbrella term for excess fat accumulation in the liver in people who drink little or no alcohol. It exists on a spectrum:
- Simple steatosis (fatty liver): Fat accumulates in liver cells, but there is minimal inflammation. Many people remain here and never progress.
- MASH (NASH): The liver becomes inflamed. Liver cells begin to die. Scar tissue forms. This is where serious long-term risk begins.
- Advanced fibrosis and cirrhosis: Scarring progresses, liver function declines. At this stage, the damage may be irreversible.
Why MASLD (NAFLD) Is Directly Tied to Metabolic Health
MASLD (NAFLD) is not primarily a liver disease in isolation — it is a metabolic disease that happens to manifest in the liver. The same factors that drive Type 2 diabetes, obesity, and cardiovascular risk drive MASLD (NAFLD):
- Insulin resistance — the liver is flooded with glucose it cannot properly process
- Excess visceral fat — fat stored around the organs rather than under the skin
- Dyslipidemia — abnormal triglyceride and cholesterol levels
- Chronic low-grade systemic inflammation
1 in 4 adults worldwide have MASLD (NAFLD) — yet most have no symptoms until the disease has already progressed significantly.
MASH (NASH) Clinical Trials: The Race for the First Approved Treatments
Until very recently, there were no FDA-approved medications specifically for MASLD (NAFLD) or MASH (NASH). The only recommended treatments were lifestyle modification — diet, exercise, and weight loss — which, while effective, are difficult to sustain long-term.
That is changing rapidly. Several drug classes are now in late-stage clinical trials showing meaningful reductions in liver fat, inflammation, and fibrosis. The pharmaceutical sponsors leading some of this research are among Mission Research Institute & study partners.
If you have been told you have an elevated liver enzyme, fatty liver on imaging, or a formal MASLD (NAFLD) or MASH (NASH) diagnosis, you may be eligible for a clinical trial that gives you access to these investigational treatments now — years before they reach standard clinical practice.
How Do You Know If You Have MASLD (NAFLD)?
Many people are diagnosed incidentally — their doctor orders routine blood work and notices elevated liver enzymes, or an ultrasound performed for another reason reveals a bright, echogenic (tissue or organ reflects sound waves) liver consistent with fat deposition. A formal diagnosis may involve a FibroScan (liver elastography), an MRI, or in some cases a liver biopsy.
If any of these apply to you, talk to your doctor — and ask about clinical research options.
MASH (NASH) is now the leading cause of liver transplants among women and adults 65 and older in the United States, and is projected to become the leading cause overall.
Understanding Fatty Liver Disease: Symptoms, Risks, and Treatment
Here are answers to common questions patients ask about fatty liver disease and how fatty liver disease clinical
trials are changing available treatment.
What is the difference between MASLD (NAFLD) and MASH (NASH) (fatty liver disease)?
MASLD (NAFLD), or metabolic dysfunction-associated steatotic liver disease, is an umbrella term for excess fat in the liver unrelated to alcohol use, affecting approximately 100 million Americans. MASH (NASH), or metabolic dysfunction-associated steatohepatitis, is a more serious progression where the liver becomes inflamed, cells begin to die, and scar tissue forms — potentially leading to cirrhosis, liver failure, or liver cancer. Many people with MASLD (NAFLD) never progress to MASH (NASH), but those who do face significant long-term health risks.
What causes fatty liver disease MASLD (NAFLD)?
MASLD (NAFLD) is primarily a metabolic disease driven by insulin resistance, excess visceral fat, abnormal triglyceride and cholesterol levels, and chronic inflammation — the same factors behind Type 2 diabetes, obesity, and cardiovascular disease. It affects 1 in 4 adults worldwide, yet most have no symptoms until the disease has already advanced significantly.
Are there clinical trials for MASLD (NAFLD) and MASH (NASH) treatment?
Yes. Until recently, no FDA-approved medications existed specifically for MASLD (NAFLD) or MASH (NASH). That is changing rapidly, with several drug classes now in late-stage clinical trials showing meaningful reductions in liver fat, inflammation, and fibrosis. Adults diagnosed with elevated liver enzymes, fatty liver on imaging, or a formal MASLD (NAFLD) or MASH (NASH) diagnosis may qualify for a clinical trial that provides access to investigational treatments at no cost — years before they reach standard care.
