Diazoxide Choline in Hypertriglyceridemia

Essentialis

Status and phase: Completed; Phase 2

Conditions: Hypertriglyceridemia

Treatments: Drug: Diazoxide choline; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00696475

PC007

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Diazoxide equivalent dose

Treatment:

Drug: Diazoxide choline

Drug: Diazoxide choline

Drug: Diazoxide choline

2

Experimental group

Description:

Diazoxide equivalent dose

Treatment:

Drug: Diazoxide choline

Drug: Diazoxide choline

Drug: Diazoxide choline

3

Experimental group

Description:

Diazoxide equivalent dose

Treatment:

Drug: Diazoxide choline

Drug: Diazoxide choline

Drug: Diazoxide choline

4

Placebo Comparator group

Treatment:

Drug: Placebo