Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia

Essentialis

Status and phase: Completed; Phase 2

Conditions: Hypertriglyceridemia; Dyslipidemia

Treatments: Drug: Diazoxide Choline Controlled-Release Tablet; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01211847

CT013

Details and patient eligibility

About

Once a day oral administration with DCCR helps lower triglycerides

Full description

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,

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

DCCR

Experimental group

Description:

DCCR Treatment with 290 mg Diazoxide Choline

Treatment:

Drug: Diazoxide Choline Controlled-Release Tablet

Placebo

Placebo Comparator group

Description:

Placebo matching DCCR

Treatment:

Drug: Placebo