Diazoxide Choline in Hypertriglyceridemia

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypertriglyceridemia

In brief

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.

Key facts

Study ID

NCT00696475

Run by

Essentialis, Inc.

People needed

80

Starts

2008-06-01

Expected to finish

2009-03-01

Last updated by the study team

2010-11-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• triglycerides ≥ 250 mg/dL and < 600 mg/dL
• BMI between 18.5 and 45
• Signed informed consent form

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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