Clinical trial NCT00696475: Diazoxide Choline in Hypertriglyceridemia
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Diazoxide Choline in Non-Diabetic Hypertriglyceridemic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertriglyceridemia
Lead sponsor: Essentialis, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2008-06-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To assess the effect on triglycerides of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects
timeFrame: 8 weeks
Secondary outcomes:
measure: 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
timeFrame: 8 weeks
measure: To assess the safety and tolerability of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami Gardens
country: United States
facility: Allied Research International/Cetero Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Kansas City
country: United States
facility: St. Luke's Lipid and Diabetes Research Center
state: Missouri
city: Winston Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Metabolic and Atherosclerosis Research Center (MARC)
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd
state: Ohio
city: Marion
country: United States
facility: Frederick C. Smith Clinic
state: Ohio
city: Bristol
country: United States
facility: TriCities Medical Research
state: Tennessee
Study officials:
affiliation: L-MARC Research Center
name: Harold Bays, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Lipid and Diabetes Research Center
name: Alan Forker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meridien Research
name: Cynthia Huffman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jacksonville Center For Clinical Research
name: Michael Koren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Research Institute
name: Andrew Lewin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Piedmont Medical Research Associates
name: Thomas Littlejohn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: TriCities Medical Research
name: David Morin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sterling Research Group, Ltd
name: Eli Roth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Metabolic and Atherosclerosis Research Center (MARC)
name: Evan Stein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Midwest Institute for Clinical Research
name: Philip Toth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Frederick C. Smith Clinic
name: Craig Thompson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Allied Research International/Cetero Research
name: Glibert Weiner, MD
role: PRINCIPAL_INVESTIGATOR
References: