Diazoxide Choline in Hypertriglyceridemia - Full Text View

Sponsor:	Essentialis, Inc.
Collaborator:	Medpace, Inc.
Information provided by:	Essentialis, Inc.
ClinicalTrials.gov Identifier:	NCT00696475

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Diazoxide Choline in Non-Diabetic Hypertriglyceridemic Subjects

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Triglycerides

Drug Information available for: Choline Choline chloride Choline dihydrogen citrate Choline bitartrate Diazoxide Choline salicylate

U.S. FDA Resources

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
Study Completion Date:	March 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

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

Locations

United States, California
National Research Institute
Los Angeles, California, United States, 90057
United States, Florida
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Allied Research International/Cetero Research
Miami Gardens, Florida, United States, 33169
Meridien Research
Tampa, Florida, United States, 33606
United States, Indiana
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States, 46260
United States, Kentucky
L-MARC Research Center
Louisville, Kentucky, United States, 40213
United States, Missouri
St. Luke's Lipid and Diabetes Research Center
Kansas City, Missouri, United States, 64111
United States, North Carolina
Piedmont Medical Research Associates
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Sterling Research Group, Ltd
Cincinnati, Ohio, United States, 45219
Metabolic and Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, United States, 45212
Frederick C. Smith Clinic
Marion, Ohio, United States, 43302
United States, Tennessee
TriCities Medical Research
Bristol, Tennessee, United States, 37620

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

No publications provided

Responsible Party:	Neil M Cowen, PhD/Chief Scientific Officer, Essentialis
ClinicalTrials.gov Identifier:	NCT00696475 History of Changes
Other Study ID Numbers:	PC007
Study First Received:	June 10, 2008
Last Updated:	November 4, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Choline
Diazoxide
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents
Antihypertensive Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012