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

Primary Purpose

Hyperlipidemia, NAFLD

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VK2809
Placebo
Sponsored by
Viking Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radiant Research, Inc.
  • SC Clinical Research
  • ACTCA
  • Catalina Research Institute
  • North America Research, Inc
  • Orange County Research Center
  • Research Institute of South Florida
  • Research Institute of South Florida
  • Avant Research Associates, LLC
  • HCI- MetroMedic Walk-in
  • HCI- MetroMedic Walk-in
  • Flint Clinical Research, PLLC
  • CHEAR Center, LLC
  • Mid Hudson Medical
  • Wake Research Associcates, LLC.
  • Avant Research
  • Clinical Trials of Texas, INC
  • Radiant Research, Inc.
  • Wasatch Clinical Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

VK2809 (5mg)

VK2809 (10mg)

VK2809 (10mg QOD)

Arm Description

Placebo capsule

5mg VK2809 capsule

10mg VK2809 capsule

10mg VK2809 capsule

Outcomes

Primary Outcome Measures

Change in LDL-C in patients receiving VK2809 compared to placebo

Secondary Outcome Measures

Full Information

First Posted
October 5, 2016
Last Updated
April 22, 2021
Sponsor
Viking Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02927184
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 28, 2016 (Actual)
Primary Completion Date
March 26, 2019 (Actual)
Study Completion Date
March 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viking Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, NAFLD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule
Arm Title
VK2809 (5mg)
Arm Type
Experimental
Arm Description
5mg VK2809 capsule
Arm Title
VK2809 (10mg)
Arm Type
Experimental
Arm Description
10mg VK2809 capsule
Arm Title
VK2809 (10mg QOD)
Arm Type
Experimental
Arm Description
10mg VK2809 capsule
Intervention Type
Drug
Intervention Name(s)
VK2809
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in LDL-C in patients receiving VK2809 compared to placebo
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Minimum of 10% liver fat as assessed by MRI - Proton Density Fat Fraction Fasting serum LDL-C >130 mg/dL at screening, >110 mg/dL on lipid lowering medications Any one of the following: Triglycerides ≥150 mg/dL or receiving prescription medication for elevated triglycerides. Systolic blood pressure >130 mmHg or diastolic blood pressure ≥85 mmHg or receiving prescription medication for hypertension. Waist circumference >40 inches (men) or >35 inches (women) Body mass index (BMI) 18.50 - 40.00 kg/m2 inclusive at screening Provide a personally-signed and dated informed consent document Exclusion Criteria: Females of childbearing potential and males unwilling to use barrier birth control method (condom) throughout the study Resting 12-lead ECG showing QTc >450 msec, any tachyarrhythmia or morphology change, or any other clinically significant abnormality Cardiovascular event requiring hospitalization in the past year History or presence of thyroid disorder History of malignancy in past 5 years LDL-C ≥190 mg/dL or familial hypercholesterolemia Significant hepatic or renal function test abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Mancini
Organizational Affiliation
Viking Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research, Inc.
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
SC Clinical Research
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Facility Name
ACTCA
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Catalina Research Institute
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
North America Research, Inc
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Research Institute of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Research Institute of South Florida
City
Miami
State/Province
Florida
Country
United States
Facility Name
Avant Research Associates, LLC
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Name
HCI- MetroMedic Walk-in
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
HCI- MetroMedic Walk-in
City
New Bedford
State/Province
Massachusetts
Country
United States
Facility Name
Flint Clinical Research, PLLC
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
CHEAR Center, LLC
City
Bronx
State/Province
New York
ZIP/Postal Code
10459
Country
United States
Facility Name
Mid Hudson Medical
City
Hopewell Junction
State/Province
New York
ZIP/Postal Code
12533
Country
United States
Facility Name
Wake Research Associcates, LLC.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Avant Research
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Clinical Trials of Texas, INC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Radiant Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Wasatch Clinical Research, LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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