Viking 2809

Condition: Nonalcoholic steatohepatitis

Eligibility

Key Inclusion Criteria

  • Confirmed diagnosis of nonalcoholic steatohepatitis
  • 18-75 years old
  • Screening MRI-PDFF with ≥8% liver fat fraction

Key Exclusion Criteria

  • Unwilling to undergo the required liver biopsy procedures or has any condition that would prevent obtaining a liver biopsy
  • Current or history of excessive alcohol consumption
  • Weight change >5% within six months prior to the qualifying liver biopsy and up to study group assignment 

Full Study Name

VK2809 A Phase IIB, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of VK2809 Administered for 52 Weeks Followed by a 4-Week, Off-Drug Phase in Subjects With Biopsy-Proven Nonalcoholic Steatohepatitis With Fibrosis (IRB no. 00000428) 

Summary

The purpose of this study is to determine the safety and effectiveness of an investigational thyroid hormone receptor drug called VK2809 for the treatment of nonalcoholic steatohepatitis (NASH). NASH causes the buildup of extra fat in the liver, resulting in liver cell degeneration. There are currently no approved medications that can treat or reverse NASH; the only available treatment for NASH patients is to make lifestyle changes such as improving diet, increasing exercise and losing weight. VK2809 is designed to reduce cholesterol and lower liver fat content. Participants will be randomly assigned to receive VK2809 (1, 2.5, 5, or 10 mg) or placebo (inactive substance).

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