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Clinical Trial NCT02927184 for Hyperlipidemia, NAFLD is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease Phase 2 59

Completed
Clinical Trial NCT02927184 was designed to study Treatment for Hyperlipidemia, NAFLD. This was a Phase 2 interventional study that is now completed. The study started on 28 September 2016, with plans to enroll 59 participants. Led by Viking Therapeutics, Inc., the expected completion date was 26 March 2019. The latest data from ClinicalTrials.gov was last updated on 26 April 2021.
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 safe...Show More
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

Conditions
HyperlipidemiaNAFLD
Other Study IDs
  • VK2809-201
NCT ID Number
NCT02927184
Start Date (Actual)
2016-09-28
Last Update Posted
2021-04-26
Completion Date (Estimated)
2019-03-26
Enrollment (Estimated)
59
Study Type
Interventional
PHASE
Phase 2
Status
Completed
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Placebo ComparatorPlacebo
Placebo capsule
Placebo
ExperimentalVK2809 (5mg)
5mg VK2809 capsule
VK2809
ExperimentalVK2809 (10mg)
10mg VK2809 capsule
VK2809
ExperimentalVK2809 (10mg QOD)
10mg VK2809 capsule
VK2809
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in LDL-C in patients receiving VK2809 compared to placebo
12 weeks
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  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

  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
Viking Therapeutics, Inc. logoViking Therapeutics, Inc.
No contact data.
19 Study Locations in 1 Countries

Arizona

Radiant Research, Inc., Chandler, Arizona, 85224, United States

California

SC Clinical Research, Garden Grove, California, 92844, United States
ACTCA, Los Angeles, California, United States
Catalina Research Institute, Montclair, California, 91763, United States
North America Research, Inc, Pomona, California, 91767, United States
Orange County Research Center, Tustin, California, 92780, United States

Florida

Research Institute of South Florida, Miami, Florida, 33173, United States
Research Institute of South Florida, Miami, Florida, United States

Louisiana

Avant Research Associates, LLC, Crowley, Louisiana, 70526, United States

Massachusetts

HCI- MetroMedic Walk-in, New Bedford, Massachusetts, 02740, United States
HCI- MetroMedic Walk-in, New Bedford, Massachusetts, United States

Michigan

Flint Clinical Research, PLLC, Flint, Michigan, 48503, United States

New York

Mid Hudson Medical, Hopewell Junction, New York, 12533, United States
CHEAR Center, LLC, The Bronx, New York, 10459, United States

North Carolina

Wake Research Associcates, LLC., Raleigh, North Carolina, 27612, United States

Texas

Avant Research, Beaumont, Texas, 77702, United States
Clinical Trials of Texas, INC, San Antonio, Texas, 78229, United States
Radiant Research, Inc., San Antonio, Texas, 78229, United States

Utah

Wasatch Clinical Research, LLC, Salt Lake City, Utah, 84107, United States