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

Phase 2

Completed

• Conditions: Hyperlipidemia; NAFLD
• Interventions: Drug: Placebo; Drug: VK2809

• Registration Number: NCT02927184
• Lead Sponsor: Viking Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-28
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Primary Completion: 2019-03-26
• Study Completion: 2019-03-26
• Disposition First Submitted: 2019-11-20
• Disposition First Submitted QC: 2019-11-20
• Disposition First Posted: 2019-11-25
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsule
VK2809 (5mg)	VK2809	5mg VK2809 capsule
VK2809 (10mg)	VK2809	10mg VK2809 capsule
VK2809 (10mg QOD)	VK2809	10mg VK2809 capsule

Primary Outcome Measures

Name	Time	Method
Change in LDL-C in patients receiving VK2809 compared to placebo	12 weeks

Trial Locations

Locations (16)

Wake Research Associcates, LLC.; 🇺🇸 Raleigh, North Carolina, United States

Flint Clinical Research, PLLC; 🇺🇸 Flint, Michigan, United States

SC Clinical Research; 🇺🇸 Garden Grove, California, United States

Catalina Research Institute; 🇺🇸 Montclair, California, United States

North America Research, Inc; 🇺🇸 Pomona, California, United States

Avant Research Associates, LLC; 🇺🇸 Crowley, Louisiana, United States

Mid Hudson Medical; 🇺🇸 Hopewell Junction, New York, United States

Radiant Research, Inc.; 🇺🇸 San Antonio, Texas, United States

ACTCA; 🇺🇸 Los Angeles, California, United States

Research Institute of South Florida; 🇺🇸 Miami, Florida, United States

Wasatch Clinical Research, LLC; 🇺🇸 Salt Lake City, Utah, United States

CHEAR Center, LLC; 🇺🇸 Bronx, New York, United States

Orange County Research Center; 🇺🇸 Tustin, California, United States

Clinical Trials of Texas, INC; 🇺🇸 San Antonio, Texas, United States

HCI- MetroMedic Walk-in; 🇺🇸 New Bedford, Massachusetts, United States

Avant Research; 🇺🇸 Beaumont, Texas, United States