Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
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
1 other identifier
interventional
59
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2016
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2016
CompletedFirst Submitted
Initial submission to the registry
October 5, 2016
CompletedFirst Posted
Study publicly available on registry
October 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2019
CompletedApril 26, 2021
April 1, 2021
2.5 years
October 5, 2016
April 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in LDL-C in patients receiving VK2809 compared to placebo
12 weeks
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo capsule
VK2809 (5mg)
EXPERIMENTAL5mg VK2809 capsule
VK2809 (10mg)
EXPERIMENTAL10mg VK2809 capsule
VK2809 (10mg QOD)
EXPERIMENTAL10mg VK2809 capsule
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Radiant Research, Inc.
Chandler, Arizona, 85224, United States
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
Research Institute of South Florida
Miami, Florida, 33173, United States
Research Institute of South Florida
Miami, Florida, United States
Avant Research Associates, LLC
Crowley, Louisiana, 70526, United States
HCI- MetroMedic Walk-in
New Bedford, Massachusetts, 02740, United States
HCI- MetroMedic Walk-in
New Bedford, Massachusetts, United States
Flint Clinical Research, PLLC
Flint, Michigan, 48503, United States
Mid Hudson Medical
Hopewell Junction, New York, 12533, United States
CHEAR Center, LLC
The Bronx, New York, 10459, United States
Wake Research Associcates, LLC.
Raleigh, North Carolina, 27612, United States
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
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marianne Mancini
Viking Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2016
First Posted
October 6, 2016
Study Start
September 28, 2016
Primary Completion
March 26, 2019
Study Completion
March 26, 2019
Last Updated
April 26, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share