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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02927184
Other study ID # VK2809-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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