You Don’t Have to Take On
An Exceptional Opportunity: The FASCINATE-2 Study
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. The FASCINATE-2 Study (SB2640-CLIN-007) is researching an investigational drug called TVB-2640 to determine if it can reverse liver damage in NASH patients with moderate to advanced fibrosis (F2-F3). If you are 18 years of age or older and have been diagnosed with NASH, you may qualify to participate in the study.
TVB-2640 is designed to target compensated cirrhosis due to NASH by reducing liver fat, inflammation, and scarring. The purpose of the FASCINATE-2 Study is to evaluate the safety and effectiveness of this investigational drug versus placebo in patients with NASH. “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 FASCINATE-2 Study and choose to participate, you will be enrolled for 52 weeks, during which you’ll be randomly assigned to receive either TVB-2640 or placebo. 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 TVB-2640 or placebo will be provided at no cost. Reimbursement for time and travel may also be available.
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