Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease

Status:	Active, not recruiting
Conditions:	High Cholesterol, Gastrointestinal, Gastrointestinal
Therapuetic Areas:	Cardiology / Vascular Diseases, Gastroenterology
Healthy:	No
Age Range:	18 - 75
Updated:	11/1/2018
Start Date:	September 28, 2016
End Date:	June 28, 2019

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

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.

Inclusion Criteria:

1. Minimum of 10% liver fat as assessed by MRI - Proton Density Fat Fraction

2. Fasting serum LDL-C >130 mg/dL at screening, >110 mg/dL on lipid lowering medications

3. Any one of the following:

1. Triglycerides ≥150 mg/dL or receiving prescription medication for elevated
triglycerides.

2. Systolic blood pressure >130 mmHg or diastolic blood pressure ≥85 mmHg or
receiving prescription medication for hypertension.

3. Waist circumference >40 inches (men) or >35 inches (women)

4. Body mass index (BMI) 18.50 - 40.00 kg/m2 inclusive at screening

5. Provide a personally-signed and dated informed consent document

Exclusion Criteria:

1. Females of childbearing potential and males unwilling to use barrier birth control
method (condom) throughout the study

2. Resting 12-lead ECG showing QTc >450 msec, any tachyarrhythmia or morphology change,
or any other clinically significant abnormality

3. Cardiovascular event requiring hospitalization in the past year

4. History or presence of thyroid disorder

5. History of malignancy in past 5 years

6. LDL-C ≥190 mg/dL or familial hypercholesterolemia

7. Significant hepatic or renal function test abnormalities

We found this trial at

sites

Clinical Trials of Texas, Inc.

7940 Floyd Curl Dr.
San Antonio, Texas 78229

210-949-0122