Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides

A Multi-Center, Randomized, Double-Blind, Placebo- and Active-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 Active-Controlled Extension Assessing Safety and Tolerability

The hypothesis of this study is that DCCR is effective as both monotherapy and in combination with a statin in lowering triglycerides in subjects with very high triglycerides

Very high triglyceride is a risk for pancreatitis. Studies have shown Diazoxide Choline has the potential to effectively lower triglycerides in patients with very high triglycerides.

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 receiving a stable and effective dose of statin for ≥ 3 months without significant side effects or intolerance prior to Screening
  • Must be willing to switch to 20 mg atorvastatin 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

Fasting LDL cholesterol

• ≤ l60 mg/dL at both Screening Visit and Visit 4

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 initial 12-week Placebo-Controlled Treatment Period of the study

Specific diagnoses, medical conditions and history

• Known type I or III hyperlipidemia
• Known type 1 DM
• Known 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