A new study conducted at the University of California, San Diego is investigating the potential benefits of the GLP-1 agonist semaglutide in the management of fibrosis due to non-alcoholic fatty liver disease (NAFLD). The trial, known as SAMARA (Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM), is specifically targeting adults with type 2 diabetes and obesity.
NAFLD is a condition characterized by fat buildup in the liver in individuals who consume little to no alcohol. If left untreated, it can progress to more severe conditions such as non-alcoholic steatohepatitis (NASH) and cirrhosis. Semaglutide is already approved for the treatment of type 2 diabetes and obesity, but its potential benefits for NAFLD are yet to be determined.
The study aims to enroll 120 participants who will receive weekly injections of either semaglutide or a placebo for one year. The researchers will monitor changes in fibrosis and other indicators of liver health. If successful, the study will advance to a larger phase 3 trial conducted at multiple sites worldwide. Positive outcomes from the phase 3 study could lead to FDA approval for semaglutide in the treatment of NAFLD.
It is estimated that liver disease is present in 60% of people with type 2 diabetes, making it an important complication to address. However, liver disease often goes unnoticed due to its lack of noticeable symptoms. The SAMARA study aims to address this issue by testing a streamlined and non-invasive screening technique to identify individuals at risk of NAFLD.
At present, there are no FDA-approved medications for the treatment of NAFLD. Lifestyle changes, including weight loss, healthier eating habits, reduced alcohol intake, and increased physical activity, are the primary recommendations. This study offers hope for an alternative treatment option.
If you are interested in participating in the study, you may be eligible if you have a BMI of at least 27 or a BMI of at least 25 with pre-diabetes, type 2 diabetes, or an A1C level of 6.5 or greater. Eligibility requires routine blood tests and a non-invasive ultrasound for liver stiffness and fat assessment.
The trial is currently recruiting participants in San Diego and may expand to include Riverside County. For more information about joining the study, you can contact the study team at [email protected] or call (858) 246-2227.
Source: Clinical Trials Identifier: NCT06005012, University of California, San Diego