The Voyage Study (VK2809-202)

Nonalcoholic steatohepatitis (NASH) is liver inflammation and damage due to a buildup of fat in the liver. Although many people with NASH do not experience any symptoms, ongoing liver damage often causes excessive scarring called fibrosis. Over time, as scar tissue replaces healthy liver tissue, fibrosis can progress to cirrhosis—a serious condition that increases the risk of liver failure and liver cancer. The causes of NASH are not fully understood, but the condition is more common in people with obesity, high blood pressure, high cholesterol, and type 2 diabetes. 

The purpose of this study is to help researchers find out if an investigational study drug is safe and effective for treating patients with NASH. Some evidence suggests that the study drug VK2809 may reduce excess fat in the liver, but the medication has not been approved by the United States Food and Drug Administration (FDA).  

• Ages 18-75
• Diagnosed with non-alcoholic steatohepatitis (NASH)
• Have not taken weight loss medications in the past 6 months
• No history of excessive alcohol consumption
• People with type 2 diabetes must have stable glycemic control (A1C < 9%)

During an initial screening period that may last up to 3 months, potential participants will undergo tests to find out if they are eligible to participate in the study. As part of this screening, a liver biopsy will be done if you have not had one in the past 6 months. If eligible, participants will be randomly assigned (like the flip of a coin) to receive the investigational study drug or a placebo. A placebo is an inactive substance that looks like the study drug. Both the study drug and the placebo are capsules taken once a day by mouth. The treatment period will last about 12 months. 

Participants will undergo a liver biopsy at visit 15 and have other tests and assessments as needed. One month after the last treatment, participants will return for one final visit.