A Phase 2 interventional study of Diazoxide choline and Diazoxide choline in Hypertriglyceridemia, sponsored by Essentialis, Inc.. Completed at 12 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-11-07.
Sponsored by Essentialis, Inc. · Phase 2, Interventional, and Treatment
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.
296 studies on the registry are indexed under Hypertriglyceridemia; 39 are open to participants now.
This study's planned enrollment of 80 is above the median of 66 across 259 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →Essentialis, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Diazoxide equivalent dose
Drug: Diazoxide choline
Diazoxide equivalent dose
Drug: Diazoxide choline
Diazoxide equivalent dose
Drug: Diazoxide choline
Drug: Placebo
To assess the effect on triglycerides of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects
Time frame: 8 weeks
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
Time frame: 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
Time frame: 8 weeks
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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Essentialis, Inc.