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

Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927184
• Other study ID #: VK2809-201
• Status: Completed
• Phase: Phase 2
• Start date: September 28, 2016
• Est. completion date: March 26, 2019

Study information

• Verified date: April 2021
• Source: Viking Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 26, 2019
• Est. primary completion date: March 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Hypercholesterolemia
• Hyperlipidemia
• Hyperlipidemias
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• VK2809

• Placebo

Locations

Country	Name	City	State
United States	Avant Research	Beaumont	Texas
United States	CHEAR Center, LLC	Bronx	New York
United States	Radiant Research, Inc.	Chandler	Arizona
United States	Avant Research Associates, LLC	Crowley	Louisiana
United States	Flint Clinical Research, PLLC	Flint	Michigan
United States	SC Clinical Research	Garden Grove	California
United States	Mid Hudson Medical	Hopewell Junction	New York
United States	ACTCA	Los Angeles	California
United States	Research Institute of South Florida	Miami	Florida
United States	Research Institute of South Florida	Miami	Florida
United States	Catalina Research Institute	Montclair	California
United States	HCI- MetroMedic Walk-in	New Bedford	Massachusetts
United States	HCI- MetroMedic Walk-in	New Bedford	Massachusetts
United States	North America Research, Inc	Pomona	California
United States	Wake Research Associcates, LLC.	Raleigh	North Carolina
United States	Wasatch Clinical Research, LLC	Salt Lake City	Utah
United States	Clinical Trials of Texas, INC	San Antonio	Texas
United States	Radiant Research, Inc.	San Antonio	Texas
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Viking Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL-C in patients receiving VK2809 compared to placebo		12 weeks