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

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ClinicalTrials.gov Identifier: NCT02927184
Recruitment Status : Active, not recruiting
First Posted : October 6, 2016
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Viking Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia NAFLD Drug: VK2809 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 28, 2016
Estimated Primary Completion Date : December 28, 2018
Estimated Study Completion Date : June 28, 2019


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



Primary Outcome Measures :
  1. Change in LDL-C in patients receiving VK2809 compared to placebo [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927184


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

Responsible Party: Viking Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02927184     History of Changes
Other Study ID Numbers: VK2809-201
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Liver Diseases
Hypercholesterolemia
Fatty Liver
Hyperlipidemias
Hyperlipoproteinemias
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases