Researchers at UC San Diego will use a $9.57 million grant to support a clinical trial to study a new treatment option for patients with nonalcoholic fatty liver disease, it was announced Wednesday.
NAFLD, an umbrella term for a range of liver conditions affecting people who drink little to no alcohol that can lead to cirrhosis, liver cancer and liver failure, impacts 24% of adults in the United States, according to the National Institutes of Health. It also has no U.S. Food and Drug Administration- approved medications to treat it.
“Liver disease is a silent killer, and most people do not know they have a liver problem until it is advanced to cirrhosis because there are no obvious symptoms,” said Dr. Rohit Loomba, chief of the division of gastroenterology and hepatology and director of the NAFLD Research Center at UCSD School of Medicine. “The results from our study could have a global impact on clinical care for patients with NAFLD and other chronic liver diseases.”
Known as the SAMARA Study, the clinical trial will examine if an FDA- approved medication called semaglutide — commonly used for the treatment of type 2 diabetes and obesity — could be a promising treatment option for patients with liver scarring caused by NAFLD, according to a university statement.
The trial will include 120 participants diagnosed with type 2 diabetes and obesity, who will either inject the drug or a placebo. Participants will administer the injection once a week and will follow a dose escalation schedule over a period of 16 weeks.
The participants will be screened with routine blood work and undergo a test for liver stiffness and liver fat using an ultrasound-based device in the patient’s primary care doctor’s office.
“Unlike other similar trials for NAFLD, the SAMARA Study is the first of its kind in that it will be screening patients for eligibility using non- invasive methods that are applicable and practical in real-world, primary care settings,” Loomba said. “By doing this in the primary care doctor’s office, we are hopeful this will provide an improvement in the detection and care for patients.”
NASH — nonalcoholic steatohepatitis — is the most severe form of NAFLD and consists of excessive fat buildup in the liver, the researchers said. Individuals who are overweight, have type 2 diabetes or have a family member with NAFLD are at a higher risk of developing the disease.
According to Loomba, it’s anticipated that NAFLD will be the leading cause of liver transplantation in the United States by 2030, with type 2 diabetes and obesity being major risk factors for significant liver fibrosis due to NAFLD.
“Being awarded this grant represents an important step toward engaging populations in research, science and medicine to improve the health of individuals currently living with NAFLD,” he said.
The completion of the SAMARA Study will be followed by a larger, multicenter, international trial, officials said.
–City News Service