Join a Trial Researching Semaglutide for Fatty Liver Disease in Type 2 Diabetes and Obesity

Join a study at UC San Diego investigating the potential benefits of the GLP-1 agonist semaglutide in non-alcoholic fatty liver disease (NAFLD). 

Clinical Trials Identifier: NCT06005012

Trial Name: Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM (SAMARA)

Diabetes Type: Adults with type 2 diabetes and obesity

Trial Sponsor: University of California, San Diego 

What is the trial researching?

This trial is investigating whether semaglutide helps manage fibrosis (scar tissue) due to non-alcoholic fatty liver disease (NAFLD). The study will also test a method of screening people with type 2 diabetes or obesity for advanced NAFLD. 

NAFLD describes a group of conditions that occur when fat builds up in the liver in people who drink little to no alcohol. If not diagnosed and managed, NAFLD can turn into non-alcoholic steatohepatitis (NASH), which occurs when there is inflammation and changes to the liver cells. NAFLD can progress to cirrhosis, or permanent scarring and liver damage. 

Semaglutide is a GLP-1 agonist that has been approved to treat type 2 diabetes (Ozempic) and obesity (Wegovy), but has not yet been approved to treat NAFLD. Since type 2 diabetes and obesity are risk factors for NAFLD, researchers have hypothesized that semaglutide may also be beneficial for liver disease given its benefits for both risk factors. 

The study aims to enroll 120 participants, who will receive weekly injections of either semaglutide or placebo treatment for one year. Researchers will track changes in fibrosis due to NAFLD, as well as other measures of liver health. 

Why is this important?

Liver disease is an overlooked diabetes complication that is estimated to be present in 60% of people with type 2 diabetes. 

Early detection is essential, but this is only possible with screening methods that are not commonly used. This study will test a more streamlined, noninvasive screening technique to identify people with type 2 diabetes and obesity who are at risk of NAFLD. 

According to study Dr. Roohit Loomba, director of the NAFLD Research Center at UC San Diego School of Medicine, liver disease is a “silent killer” since symptoms aren’t very noticeable and many people aren’t aware of the disease until they have cirrhosis. 

Currently, there are no medications approved by the FDA to treat NAFLD. The only available treatment today consists of lifestyle changes, including ​​weight loss and management, eating healthy, reducing alcohol intake, and increasing physical activity.

If this study is successful, semaglutide will progress to a larger phase 3 study conducted at multiple sites across the world. Upon successful results in the phase 3 study, semaglutide would be submitted to the FDA for review.

Are you interested?

You may be eligible to participate if you:

• Are between the age of 40-79 years 

• Qualify for one of the following two criteria:

1. Have a BMI of at least 27, or

2. Have a BMI of at least 25 as well as one of the following:

• Pre-diabetes (A1C between 5.7-6.4)

• Have been diagnosed with type 2 diabetes

• An A1C of 6.5 or greater

In order to participate, you’ll need to be screened through routine blood tests. You’ll also undergo a brief, non-invasive ultrasound for liver stiffness and liver fat in your primary care doctor’s office. 

The trial is currently recruiting in San Diego, and may expand to include Riverside county. See a full list of inclusion/exclusion criteria here. 

For more information: To learn more about this study, contact the study team at emadamba@health.ucsd.edu or call (858) 246-2227.