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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02927184
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Viking Therapeutics, Inc.

Study Description
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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 Design
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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
Actual Primary Completion Date : March 26, 2019
Actual Study Completion Date : March 26, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


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

Eligibility Criteria
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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
Contacts and Locations
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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
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Sponsors and Collaborators
Viking Therapeutics, Inc.
Investigators
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Study Director: Marianne Mancini Viking Therapeutics, Inc.
More Information
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Responsible Party: Viking Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02927184    
Other Study ID Numbers: VK2809-201
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Hypercholesterolemia
Hyperlipidemias
 Digestive System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases