Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia

Study Overview
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Brief Summary
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Once a day oral administration with DCCR helps lower triglycerides

Detailed Description
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The population will consist of Statin-naive and Statin-treated subjects, all without diabetes mellitus, with fasting triglyceride levels in the range of ≥ 500 mg/dL and < 1500 mg/dL. Subjects will be randomly assigned to 1 of 2 treatment groups: DCCR and Placebo Approximately 44 subjects will be enrolled in the study and stratified by Statin use at a 1:1 ratio in each treatment group,

Official Title
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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects Without Diabetes Mellitus Having Very High Fasting Triglyceride Levels, With Double-Blind DCCR-Fenofibrate Combination Extension

Conditions
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Hypertriglyceridemia, Dyslipidemia

Intervention / Treatment
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* Drug: Diazoxide Choline Controlled-Release Tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Fasting triglycerides Difference between Visit 3 (7 days prior to Baseline Visit) and Visit 4 (3 days prior to Baseline Visit) ≤ 60% (compared to the higher value of Visit 3 or Visit 4) Run-in Triglycerides* ≥ 500 mg/dL and < 1500 mg/dL *Run-in Triglyceride is defined as the average fasting triglycerides for Visit 3 (7 days prior to Baseline Visit) and Visit 4 (3 days prior to Baseline Visit). Statin use • Either Statin-naive Must not be on statin at Screening and remaining as such during the Run-in/Washout Period and throughout the study • Or Statin-treated Must be on Lipitor 20 mg initiated at the start of the Run-in/Washout Period and continue throughout the study Medication washout All subjects must be willing to undergo washout of all other lipid-lowering medications Glycemic status Fasting glucose < 126 mg/dL at Screening Visit HbA1c < 6.5% at Screening Visit EXCLUSION CRITERIA: Medications: recent, current, anticipated Administration of investigational drugs within 1 month prior to Screening Visit Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month) Thiazide diuretics within 2 weeks prior to Screening Visit Discontinuation of beta-blockers within 1 month prior to Screening Visit or planned discontinuation of beta-blocker therapy Anticipated requirement for use of prohibited concomitant medications History of allergic reaction or significant intolerance to: Diazoxide Thiazides Sulfonamides Fenofibrate or fenofibric acid derivatives Lifestyle changes • Subjects intending to change exercise habits, quit smoking and/or quit alcohol use during the entire study Specific diagnoses, medical conditions and history Known type I or III hyperlipidemia Known type 1 DM Current diagnosis of type 2 DM Any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the study medications, according to the Investigator Specific laboratory test results • Any relevant biochemical abnormality interfering with the assessments of the study medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCCR<br>DCCR Treatment with 290 mg Diazoxide Choline | Drug: Diazoxide Choline Controlled-Release Tablet<br>* DCCR 290 mg once a day for 126 days<br>|
| Placebo Comparator: Placebo<br>Placebo matching DCCR | Drug: Placebo<br>* Placebo matching DCCR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride-lowering efficacy of DCCR | Fasting triglycerides (percent change from Baseline to Day 84) | 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in other lipid profiles with DCCR | Apolipoprotein B (Apo B) (percent change from Baseline to Day 84) Fasting non-HDL cholesterol (percent change from Baseline to Day 84) | 84 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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triglycerides, Apo B, non-HDL, statin, fenofibrate