Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02927184
Previous Study | Return to List | Next Study

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 : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Viking Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE October 5, 2016
First Posted Date  ICMJE October 6, 2016
Last Update Posted Date May 23, 2019
Actual Study Start Date  ICMJE September 28, 2016
Actual Primary Completion Date March 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2016)
Change in LDL-C in patients receiving VK2809 compared to placebo [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02927184 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperlipidemia
  • NAFLD
Intervention  ICMJE
  • Drug: VK2809
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo capsule
    Intervention: Drug: Placebo
  • Experimental: VK2809 (5mg)
    5mg VK2809 capsule
    Intervention: Drug: VK2809
  • Experimental: VK2809 (10mg)
    10mg VK2809 capsule
    Intervention: Drug: VK2809
  • Experimental: VK2809 (10mg QOD)
    10mg VK2809 capsule
    Intervention: Drug: VK2809
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2018)
59
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2016)
80
Actual Study Completion Date  ICMJE March 26, 2019
Actual Primary Completion Date March 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02927184
Other Study ID Numbers  ICMJE VK2809-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Viking Therapeutics, Inc.
Study Sponsor  ICMJE Viking Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Marianne Mancini Viking Therapeutics, Inc.
PRS Account Viking Therapeutics, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP