About the Study
High Cholesterol and Non-Alcoholic Liver Disease
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of VK2809 Administered for 12 Weeks Followed by a 4-Week Off-Drug Phase in Patients with Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
Hyperlipidemia is a disease in which cholesterol or triglycerides and associated lipoproteins are elevated in the bloodstream. Hyperlipidemia contributes to the development of cardiovascular disease and fatty liver disease. In recent decades, lipid-modulating drugs have emerged as a very successful way to treat hyperlipidemia and reduce the risk of cardiovascular disease. More recently, drugs that target the thyroid hormone receptor have also been investigated as a new way to help regulate low density lipoproteins.
This study will examine the safety and effectiveness of an investigational thyroid hormone receptor drug, called VK2809, which may help reduce cholesterol and lower liver fat content. This study is experimental. An “investigational drug” means that VK2809 is being tested and has not been approved by the Food and Drug Administration (FDA) for use by the general public. The FDA has allowed the investigational use of VK2809 in this research study. This ICF will also refer to VK2809 as the “study treatment.”
Location: Draper, UT