Diazoxide Choline in Hypertriglyceridemia

Sponsor

Essentialis, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00696475

Collaborator

Medpace, Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

6.7

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertriglyceridemia	Drug: Diazoxide choline Drug: Diazoxide choline Drug: Diazoxide choline Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

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 [8 weeks]

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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	National Research Institute	Los Angeles	California	United States	90057
2	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
3	Allied Research International/Cetero Research	Miami Gardens	Florida	United States	33169
4	Meridien Research	Tampa	Florida	United States	33606
5	Midwest Institute for Clinical Research	Indianapolis	Indiana	United States	46260
6	L-MARC Research Center	Louisville	Kentucky	United States	40213
7	St. Luke's Lipid and Diabetes Research Center	Kansas City	Missouri	United States	64111
8	Piedmont Medical Research Associates	Winston Salem	North Carolina	United States	27103
9	Metabolic and Atherosclerosis Research Center (MARC)	Cincinnati	Ohio	United States	45212
10	Sterling Research Group, Ltd	Cincinnati	Ohio	United States	45219
11	Frederick C. Smith Clinic	Marion	Ohio	United States	43302
12	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00696475

Other Study ID Numbers:

PC007

First Posted:

Jun 12, 2008

Last Update Posted:

Nov 7, 2010

Last Verified:

Nov 1, 2010

Additional relevant MeSH terms:

Hypertriglyceridemia

Diazoxide

Choline

Study Results

No Results Posted as of Nov 7, 2010