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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)

Study category: Digestive Health

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Description

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.

Details
Age

Adult

Eligibility

Requirements to Enter Study (things that must be true for you): - 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 Talk to your study staff for a complete list of inclusion/exclusion criteria

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Thomas Campbell

Thomas Campbell

Study ID

Protocol Number: 19-2824

ClinicalTrials.gov: NCT04216589

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