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

April 22, 2021 updated by: Viking Therapeutics, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Radiant Research, Inc.
    • California
      • Garden Grove, California, United States, 92844
        • SC Clinical Research
      • Los Angeles, California, United States
        • Actca
      • Montclair, California, United States, 91763
        • Catalina Research Institute
      • Pomona, California, United States, 91767
        • North America Research, Inc
      • Tustin, California, United States, 92780
        • Orange County Research Center
    • Florida
      • Miami, Florida, United States
        • Research Institute of South Florida
      • Miami, Florida, United States, 33173
        • Research Institute of South Florida
    • Louisiana
      • Crowley, Louisiana, United States, 70526
        • Avant Research Associates, LLC
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
        • HCI- MetroMedic Walk-in
      • New Bedford, Massachusetts, United States
        • HCI- MetroMedic Walk-in
    • Michigan
      • Flint, Michigan, United States, 48503
        • Flint Clinical Research, PLLC
    • New York
      • Bronx, New York, United States, 10459
        • CHEAR Center, LLC
      • Hopewell Junction, New York, United States, 12533
        • Mid Hudson Medical
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associcates, LLC.
    • Texas
      • Beaumont, Texas, United States, 77702
        • Avant Research
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc
      • San Antonio, Texas, United States, 78229
        • Radiant Research, Inc.
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo capsule
Drug: Placebo
Experimental: VK2809 (5mg)
5mg VK2809 capsule
Drug: VK2809
Experimental: VK2809 (10mg)
10mg VK2809 capsule
Drug: VK2809
Experimental: VK2809 (10mg QOD)
10mg VK2809 capsule
Drug: VK2809

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in LDL-C in patients receiving VK2809 compared to placebo
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Viking Therapeutics, Inc.

Investigators

  • Study Director: Marianne Mancini, Viking Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2016

Primary Completion (Actual)

March 26, 2019

Study Completion (Actual)

March 26, 2019

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VK2809-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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