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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02927184

Enrollment

Registered

2016-10-06

Start date

2016-09-28

Completion date

2019-03-26

Last updated

2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, NAFLD

Brief summary

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.

Interventions

DRUGVK2809

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in LDL-C in patients receiving VK2809 compared to placebo	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026