Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Hyperlipidemia, NAFLD
In brief
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.
Key facts
- Study ID
- NCT02927184
- Run by
- Viking Therapeutics, Inc.
- People needed
- 59
- Starts
- 2016-09-28
- Expected to finish
- 2019-03-26
- Last updated by the study team
- 2021-04-26
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Radiant Research, Inc. — Chandler, Arizona, United States
- SC Clinical Research — Garden Grove, California, United States
- ACTCA — Los Angeles, California, United States
- Catalina Research Institute — Montclair, California, United States
- North America Research, Inc — Pomona, California, United States
- Orange County Research Center — Tustin, California, United States
- Research Institute of South Florida — Miami, Florida, United States
- Research Institute of South Florida — Miami, Florida, United States
- Avant Research Associates, LLC — Crowley, Louisiana, United States
- HCI- MetroMedic Walk-in — New Bedford, Massachusetts, United States
- HCI- MetroMedic Walk-in — New Bedford, Massachusetts, United States
- Flint Clinical Research, PLLC — Flint, Michigan, United States
- Mid Hudson Medical — Hopewell Junction, New York, United States
- CHEAR Center, LLC — The Bronx, New York, United States
- Wake Research Associcates, LLC. — Raleigh, North Carolina, United States
- Avant Research — Beaumont, Texas, United States
- Clinical Trials of Texas, INC — San Antonio, Texas, United States
- Radiant Research, Inc. — San Antonio, Texas, United States
- Wasatch Clinical Research, LLC — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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