A5371: A Single-Arm, Open-Label, Pilot Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome with Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)

HIV comorbidities and complications

About 30-40% of people living with HIV have a condition called NAFLD, or non-alcoholic fatty liver disease.  NAFLD is caused by high levels of stored fat in the liver. Most people with NAFLD also have other complications like high cholesterol, obesity, increased belly fat or type 2 diabetes. These complications can lead to cardiovascular disease (any disease of the heart or blood vessels that can lead to a stroke or heart attack).  In fact, most of the health problems that are associated with NAFLD are related to these conditions of the heart or metabolism.  Without treatment, NAFLD can advance to more serious liver disease. By using a drug that can lower the level of stored fat in the liver, people living with HIV may be able to treat NAFLD and reduce their risk of cardiovascular disease and other complications.

The purpose of this study is to evaluate the safety and tolerability of a drug called semaglutide and to see if it can reduce the amount of fat stored in the liver.

• Living with HIV with 2 HIV viral loads less than 50 copies in the last year and a CD4 T-cell count of at least 200
• On your current HIV medications for at least 24 weeks
• Willingness to have MRI scans
• Agree to use contraception/birth control methods (if needed)
• Able to store semaglutide in a cool location
• Be 18 years old or older
• Be willing to sign the consent after discussion with the research staff
• Be willing to give yourself an injection once a week

Exclusion Criteria (things that cannot be true for you):

• Hepatitis B or C Virus infection (not previously treated)
• Any plans to change diet or exercise significantly during the study period
• Breastfeeding, pregnancy, or plans to become pregnant while on study
• Liver disease with cirrhosis
• Current diabetes mellitus
• Chronic pancreatitis
• Prior gastric (stomach) surgery (lab band, gastric sleeve or gastric bypass surgery) or plans to undergo one of these surgeries in the near future
• High alcohol use

• Blood tests at clinic visits
• Stool collections
• MRI scans
• Adherence monitoring, physical function assessment, food diary, and questionnaires

• Semaglutide subcutaneous injection once weekly for 24 weeks.

Approximately 48 weeks