Diazoxide Choline in Hypertriglyceridemia

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Diazoxide Choline in Non-Diabetic Hypertriglyceridemic Subjects

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: Diazoxide choline
* Drug: Diazoxide choline
* Drug: Diazoxide choline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: triglycerides ≥ 250 mg/dL and < 600 mg/dL BMI between 18.5 and 45 Signed informed consent form Exclusion Criteria: Fasting glucose ≥ 126 mg/dL Glycosylated hemoglobin (HbA1c) > 6.5% LDL cholesterol > 190 mg/dL Known history of type I and II DM Known history of type I and III hyperlipidemia Weight change > 3 kg between screening and baseline visits Pregnancy or intention to become pregnant Presence of significant underlying conditions that may interfere with the assessments of the study drug

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Diazoxide equivalent dose | Drug: Diazoxide choline<br> <br> |
| Experimental: 2<br>Diazoxide equivalent dose | Drug: Diazoxide choline<br> <br> |
| Experimental: 3<br>Diazoxide equivalent dose | Drug: Diazoxide choline<br> <br> |
| Placebo Comparator: 4<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect on triglycerides of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 |  | 8 weeks |