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Completed

NCT Number: NCT02927184

Safety and Tolerability of VK2809 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.

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Key information

Conditions

Hyperlipidemia Digestive System Diseases Dyslipidemias Fatty Liver Hyperlipidemias Lipid Metabolism Disorders Liver Diseases Metabolic Diseases NAFLD Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Radiant Research, Inc., Chandler, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

VK2809

Drug

Placebo

Drug

Primary outcomes

  1. Change in LDL-C in patients receiving VK2809 compared to placebo

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Viking Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 6, 2016
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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