Diazoxide Choline in Hypertriglyceridemia

Hypertriglyceridemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696475
• Other study ID #: PC007
• Status: Completed
• Phase: Phase 2
• First received: June 10, 2008
• Last updated: November 4, 2010
• Start date: June 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2010
• Source: Essentialis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• Diazoxide choline

• Diazoxide choline

• Diazoxide choline

• Placebo

Locations

Country	Name	City	State
United States	TriCities Medical Research	Bristol	Tennessee
United States	Metabolic and Atherosclerosis Research Center (MARC)	Cincinnati	Ohio
United States	Sterling Research Group, Ltd	Cincinnati	Ohio
United States	Midwest Institute for Clinical Research	Indianapolis	Indiana
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	St. Luke's Lipid and Diabetes Research Center	Kansas City	Missouri
United States	National Research Institute	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Frederick C. Smith Clinic	Marion	Ohio
United States	Allied Research International/Cetero Research	Miami Gardens	Florida
United States	Meridien Research	Tampa	Florida
United States	Piedmont Medical Research Associates	Winston Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Essentialis, Inc.	Medpace, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes