Clinical trialNCT00696475CompletedPhase 2Interventional

Diazoxide Choline in Hypertriglyceridemia

SponsorEssentialis, Inc.Enrollment80Hypertriglyceridemia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Alan Forker, MD
St. Luke's Lipid and Diabetes Research Center
Principal Investigator
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Andrew Lewin, MD
National Research Institute
Principal Investigator
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Craig Thompson, MD
Frederick C. Smith Clinic
Principal Investigator
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Cynthia Huffman, MD
Meridien Research
Principal Investigator
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David Morin, MD
TriCities Medical Research
Principal Investigator
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Eli Roth, MD
Sterling Research Group, Ltd
Principal Investigator
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Evan Stein, MD
Metabolic and Atherosclerosis Research Center (MARC)
Principal Investigator
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Glibert Weiner, MD
Allied Research International/Cetero Research
Principal Investigator
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Harold Bays, MD
L-MARC Research Center
Principal InvestigatorKOL profile →
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Michael Koren, MD
Jacksonville Center For Clinical Research
Principal Investigator
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Philip Toth, MD
Midwest Institute for Clinical Research
Principal Investigator
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Thomas Littlejohn, MD
Piedmont Medical Research Associates
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Diazoxide →Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Jun 2008
Primary completion: 31 Jan 2009
Completion: 31 Mar 2009
Last update posted: 8 Nov 2010
Registered enrollment: 80
Registry id: NCT00696475

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.