Diazoxide Choline in Hypertriglyceridemia
- Registration Number
- NCT00696475
- Lead Sponsor
- Essentialis, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- triglycerides ≥ 250 mg/dL and < 600 mg/dL
- BMI between 18.5 and 45
- Signed informed consent form
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 Placebo - 1 Diazoxide choline Diazoxide equivalent dose 2 Diazoxide choline Diazoxide equivalent dose 3 Diazoxide choline Diazoxide equivalent dose
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (12)
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Allied Research International/Cetero Research
🇺🇸Miami Gardens, Florida, United States
National Research Institute
🇺🇸Los Angeles, California, United States
Meridien Research
🇺🇸Tampa, Florida, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Piedmont Medical Research Associates
🇺🇸Winston Salem, North Carolina, United States
Midwest Institute for Clinical Research
🇺🇸Indianapolis, Indiana, United States
Frederick C. Smith Clinic
🇺🇸Marion, Ohio, United States
Sterling Research Group, Ltd
🇺🇸Cincinnati, Ohio, United States
St. Luke's Lipid and Diabetes Research Center
🇺🇸Kansas City, Missouri, United States
Metabolic and Atherosclerosis Research Center (MARC)
🇺🇸Cincinnati, Ohio, United States
TriCities Medical Research
🇺🇸Bristol, Tennessee, United States