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

NCT ID: NCT02927184

Last Updated: 2021-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-28

Study Completion Date

2019-03-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperlipidemia NAFLD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

VK2809 (5mg)

5mg VK2809 capsule

Group Type EXPERIMENTAL

VK2809

Intervention Type DRUG

VK2809 (10mg)

10mg VK2809 capsule

Group Type EXPERIMENTAL

VK2809

Intervention Type DRUG

VK2809 (10mg QOD)

10mg VK2809 capsule

Group Type EXPERIMENTAL

VK2809

Intervention Type DRUG

Interventions

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VK2809

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Viking Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marianne Mancini

Role: STUDY_DIRECTOR

Viking Therapeutics, Inc.

Locations

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Radiant Research, Inc.

Chandler, Arizona, United States

Site Status

SC Clinical Research

Garden Grove, California, United States

Site Status

ACTCA

Los Angeles, California, United States

Site Status

Catalina Research Institute

Montclair, California, United States

Site Status

North America Research, Inc

Pomona, California, United States

Site Status

Orange County Research Center

Tustin, California, United States

Site Status

Research Institute of South Florida

Miami, Florida, United States

Site Status

Research Institute of South Florida

Miami, Florida, United States

Site Status

Avant Research Associates, LLC

Crowley, Louisiana, United States

Site Status

HCI- MetroMedic Walk-in

New Bedford, Massachusetts, United States

Site Status

HCI- MetroMedic Walk-in

New Bedford, Massachusetts, United States

Site Status

Flint Clinical Research, PLLC

Flint, Michigan, United States

Site Status

Mid Hudson Medical

Hopewell Junction, New York, United States

Site Status

CHEAR Center, LLC

The Bronx, New York, United States

Site Status

Wake Research Associcates, LLC.

Raleigh, North Carolina, United States

Site Status

Avant Research

Beaumont, Texas, United States

Site Status

Clinical Trials of Texas, INC

San Antonio, Texas, United States

Site Status

Radiant Research, Inc.

San Antonio, Texas, United States

Site Status

Wasatch Clinical Research, LLC

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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VK2809-201

Identifier Type: -

Identifier Source: org_study_id

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