Hypertriglyceridemia Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Diazoxide Choline in Non-Diabetic Hypertriglyceridemic Subjects
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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