Diazoxide Choline in Hypertriglyceridemia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hypertriglyceridemia	Drug: Diazoxide choline Drug: Placebo	Phase II

MedlinePlus related topics:

Triglycerides

ChemIDplus related topics:

Diazoxide Choline Choline bitartrate Choline chloride Choline dihydrogen citrate Choline salicylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Essentialis, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	June 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Diazoxide equivalent dose	Drug: Diazoxide choline
2: Experimental Diazoxide equivalent dose	Drug: Diazoxide choline
3: Experimental Diazoxide equivalent dose	Drug: Diazoxide choline
4: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696475

Contacts


Contact: Yu Liu, MD, PhD, MBA	760-431-2646	yliu@essentialistherapeutics.com

Contact: Neil M Cowen, PhD, MBA	760-431-2646	nmcowen@essentialistherapeutics.com

Locations


United States, California
	National Research Institute	Recruiting
	Los Angeles, California, United States, 90057
	Contact: Jose Diaz-Orellana 213-483-1800
	Principal Investigator: Andrew Lewin, MD

United States, Florida
	Meridien Research	Recruiting
	Tampa, Florida, United States, 33606
	Contact: Linda Fuchek 813-877-8839
	Principal Investigator: Cynthia Huffman, MD
	Jacksonville Center for Clinical Research	Recruiting
	Jacksonville, Florida, United States, 32216
	Contact: Amber Devries 904-732-6665
	Principal Investigator: Michael Koren, MD
	Allied Research International/Cetero Research	Recruiting
	Miami Gardens, Florida, United States, 33169
	Contact: Glibert Weiner, MD 305-624-9191
	Principal Investigator: Glibert Weiner, MD

United States, Indiana
	Midwest Institute for Clinical Research	Recruiting
	Indianapolis, Indiana, United States, 46260
	Contact: Nina Garrett 317-705-7050
	Principal Investigator: Philip Toth, MD

United States, Kentucky
	L-MARC Research Center	Recruiting
	Louisville, Kentucky, United States, 40213
	Contact: Neva Williams 502-214-3945
	Principal Investigator: Harold Bays, MD

United States, Missouri
	St. Luke's Lipid and Diabetes Research Center	Recruiting
	Kansas City, Missouri, United States, 64111
	Contact: Sheryl Windsor 816-932-9858
	Principal Investigator: Alan Forker, MD

United States, North Carolina
	Piedmont Medical Research Associates	Recruiting
	Winston Salem, North Carolina, United States, 27103
	Contact: Jennifer Short 336-768-8062
	Principal Investigator: Thomas Littlejohn, MD

United States, Ohio
	Sterling Research Group, Ltd	Recruiting
	Cincinnati, Ohio, United States, 45219
	Contact: Jeanne Papania 513-381-4100 ext 106
	Principal Investigator: Eli Roth, MD
	Metabolic and Atherosclerosis Research Center (MARC)	Recruiting
	Cincinnati, Ohio, United States, 45212
	Contact: Anne Nyktas 513-579-8811
	Principal Investigator: Evan Stein, MD
	Frederick C. Smith Clinic	Recruiting
	Marion, Ohio, United States, 43302
	Contact: Donna Bender 740-383-7039
	Principal Investigator: Craig Thompson, MD

United States, Tennessee
	TriCities Medical Research	Recruiting
	Bristol, Tennessee, United States, 37620
	Contact: Sabrina Buchanan 423-989-3105
	Principal Investigator: David Morin, MDs

Sponsors and Collaborators

Essentialis, Inc.

Medpace, Inc.

Investigators


Principal Investigator:	Harold Bays, MD	L-MARC Research Center

Principal Investigator:	Alan Forker, MD	St. Luke's Lipid and Diabetes Research Center

Principal Investigator:	Cynthia Huffman, MD	Meridien Research

Principal Investigator:	Michael Koren, MD	Jacksonville Center for Clinical Research

Principal Investigator:	Andrew Lewin, MD	National Research Institute

Principal Investigator:	Thomas Littlejohn, MD	Piedmont Medical Research Associates

Principal Investigator:	David Morin, MD	TriCities Medical Research

Principal Investigator:	Eli Roth, MD	Sterling Research Group, Ltd

Principal Investigator:	Evan Stein, MD	Metabolic and Atherosclerosis Research Center (MARC)

Principal Investigator:	Philip Toth, MD	Midwest Institute for Clinical Research

Principal Investigator:	Craig Thompson, MD	Frederick C. Smith Clinic

Principal Investigator:	Glibert Weiner, MD	Allied Research International/Cetero Research

More Information

Responsible Party:	Essentialis ( Yu Liu MD, PhD, MBA Vice President of Clinical Development )
Study ID Numbers:	PC007
First Received:	June 10, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00696475
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Choline

Metabolic Diseases

Hyperlipidemias

Hypertriglyceridemia

Diazoxide

Metabolic disorder

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Nootropic Agents

Lipotropic Agents

Vasodilator Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Gastrointestinal Agents

Cardiovascular Agents

Antihypertensive Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Essentialis, Inc. Medpace, Inc.
Information provided by:	Essentialis, Inc.
ClinicalTrials.gov Identifier:	NCT00696475