Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
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This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering LDL-C and liver fat content in patients with primary hypercholesterolemia and fatty liver disease. The primary efficacy endpoint is percent change from baseline LDL-C at the end of the treatment period (Week 12). Secondary endpoints include effects on liver fat content and other liver and lipid markers, as well as effects on safety and tolerability, and pharmacokinetic (PK) measurements.
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
Actual Study Start Date :
September 28, 2016
Actual Primary Completion Date :
March 26, 2019
Actual Study Completion Date :
March 26, 2019
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Minimum of 10% liver fat as assessed by MRI - Proton Density Fat Fraction
Fasting serum LDL-C >130 mg/dL at screening, >110 mg/dL on lipid lowering medications
Any one of the following:
Triglycerides ≥150 mg/dL or receiving prescription medication for elevated triglycerides.
Systolic blood pressure >130 mmHg or diastolic blood pressure ≥85 mmHg or receiving prescription medication for hypertension.
Waist circumference >40 inches (men) or >35 inches (women)
Body mass index (BMI) 18.50 - 40.00 kg/m2 inclusive at screening
Provide a personally-signed and dated informed consent document
Females of childbearing potential and males unwilling to use barrier birth control method (condom) throughout the study
Resting 12-lead ECG showing QTc >450 msec, any tachyarrhythmia or morphology change, or any other clinically significant abnormality
Cardiovascular event requiring hospitalization in the past year
History or presence of thyroid disorder
History of malignancy in past 5 years
LDL-C ≥190 mg/dL or familial hypercholesterolemia
Significant hepatic or renal function test abnormalities