Hypertriglyceridemia affects 30% of the population in the US. Very high level of triglycerides is a known risk factor for pancreatitis. In addition, studies have shown that hypertriglyceridemia is an independent risk factor for cardiovascular disease. Diazoxide is a KATP channel opener. It has been approved by the FDA as an oral suspension for the treatment of hyperinsulinemic hypoglycemic conditions and as an IV solution for malignant hypertension. Preclinical and clinical studies suggest that diazoxide can be a potential therapeutic agent for hypertriglyceridemia. Diazoxide choline is a novel, highly crystalline proprietary salt of diazoxide, which has been formulated as a controlled-release tablet suitable for once per day dosing. This current study is designed to assess the effect of diazoxide choline on triglycerides in subjects with baseline hypertriglyceridemia. In addition, the effects on other lipid parameters, glucose and insulin, body weight as well as the safety and tolerability of diazoxide choline will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
National Research Institute
Los Angeles, California, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Allied Research International/Cetero Research
Miami Gardens, Florida, United States
Meridien Research
Tampa, Florida, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States
L-MARC Research Center
Louisville, Kentucky, United States
St. Luke's Lipid and Diabetes Research Center
Kansas City, Missouri, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States
Metabolic and Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, United States
Sterling Research Group, Ltd
Cincinnati, Ohio, United States
...and 2 more locations
To assess the effect on triglycerides of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects
Time frame: 8 weeks
To assess the effect on other lipid parameters (LDL, HDL, VLDL, and non-HDL cholesterol), insulin, glucose and weight of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects
Time frame: 8 weeks
To assess the safety and tolerability of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects
Time frame: 8 weeks
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