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A Research Opportunity
Nonalcoholic steatohepatitis (NASH) is a common form of liver disease caused by fat cells stored in the liver and is accompanied by inflammation and liver cell damage. Over time, NASH can cause liver fibrosis (scarring) and may lead to cirrhosis or liver cancer. This study sponsored by Gilead (GS-US-454-6075) is researching whether the combination of a drug called semaglutide (SEMA) with investigational drugs cilofexor/firsocostat (CILO/FIR) can reverse liver damage, reduction in fibrosis, or NASH resolution in people with compensated cirrhosis due to NASH. If you are 18 to 80 years of age and have been diagnosed with NASH, you may qualify to participate in the study. SEMA has not been approved for this indication, CILO/FIR are investigational compounds. The safety and efficacy of these drugs has not been established for this use. There is no guarantee that these drugs will be approved by the US food and Drug Administration.
SEMA is designed to target adults with type 2 diabetes. The purpose of this Gilead study is to evaluate the safety and effectiveness of SEMA with investigational drugs, CILO/FIR, versus placebo in patients with NASH to see if it can cause fibrosis improvement. “Investigational” means that this drug has not yet been approved by the US Food and Drug Administration (FDA), and its use is being allowed for research purposes only.
If you qualify for the Gilead study and choose to participate, you will be enrolled for 72 weeks, during which you’ll be randomly assigned to receive either SEMA plus CILO/FIR or SEMA plus CILO/FIR placebo or CILO/FIR plus SEMA placebo or placebo only. A placebo looks just like the investigational drug but contains no active medication. Neither you nor the study doctor will know which you are receiving until the end of the study, but in the case of an emergency, the study doctor can quickly find out.
All study-related office visits, medical procedures, laboratory tests, and study drug (either placebo or SEMA and CILO/FIR) will be provided at no cost. Reimbursement for time and travel may also be available.
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