Clinical trial NCT02927184: Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperlipidemia
NAFLD
Lead sponsor: Viking Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-06
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in LDL-C in patients receiving VK2809 compared to placebo
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Garden Grove
country: United States
facility: SC Clinical Research
state: California
city: Los Angeles
country: United States
facility: ACTCA
state: California
city: Montclair
country: United States
facility: Catalina Research Institute
state: California
city: Pomona
country: United States
facility: North America Research, Inc
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Miami
country: United States
facility: Research Institute of South Florida
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida
state: Florida
city: Crowley
country: United States
facility: Avant Research Associates, LLC
state: Louisiana
city: New Bedford
country: United States
facility: HCI- MetroMedic Walk-in
state: Massachusetts
city: New Bedford
country: United States
facility: HCI- MetroMedic Walk-in
state: Massachusetts
city: Flint
country: United States
facility: Flint Clinical Research, PLLC
state: Michigan
city: Bronx
country: United States
facility: CHEAR Center, LLC
state: New York
city: Hopewell Junction
country: United States
facility: Mid Hudson Medical
state: New York
city: Raleigh
country: United States
facility: Wake Research Associcates, LLC.
state: North Carolina
city: Beaumont
country: United States
facility: Avant Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, INC
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
state: Utah
Study officials:
affiliation: Viking Therapeutics, Inc.
name: Marianne Mancini
role: STUDY_DIRECTOR
References: