search
Back to results

Diazoxide Choline in Hypertriglyceridemia

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Diazoxide choline
Diazoxide choline
Diazoxide choline
Placebo
Sponsored by
Essentialis, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Research Institute
  • Jacksonville Center for Clinical Research
  • Allied Research International/Cetero Research
  • Meridien Research
  • Midwest Institute for Clinical Research
  • L-MARC Research Center
  • St. Luke's Lipid and Diabetes Research Center
  • Piedmont Medical Research Associates
  • Metabolic and Atherosclerosis Research Center (MARC)
  • Sterling Research Group, Ltd
  • Frederick C. Smith Clinic
  • TriCities Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Diazoxide equivalent dose

Diazoxide equivalent dose

Diazoxide equivalent dose

Outcomes

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

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
To assess the safety and tolerability of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects

Full Information

First Posted
June 10, 2008
Last Updated
November 4, 2010
Sponsor
Essentialis, Inc.
Collaborators
Medpace, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00696475
Brief Title
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

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Essentialis, Inc.
Collaborators
Medpace, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Diazoxide equivalent dose
Arm Title
2
Arm Type
Experimental
Arm Description
Diazoxide equivalent dose
Arm Title
3
Arm Type
Experimental
Arm Description
Diazoxide equivalent dose
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Diazoxide choline
Intervention Type
Drug
Intervention Name(s)
Diazoxide choline
Intervention Type
Drug
Intervention Name(s)
Diazoxide choline
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harold Bays, MD
Organizational Affiliation
L-MARC Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Forker, MD
Organizational Affiliation
St. Luke's Lipid and Diabetes Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cynthia Huffman, MD
Organizational Affiliation
Meridien Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Koren, MD
Organizational Affiliation
Jacksonville Center For Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Lewin, MD
Organizational Affiliation
National Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Littlejohn, MD
Organizational Affiliation
Piedmont Medical Research Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Morin, MD
Organizational Affiliation
TriCities Medical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eli Roth, MD
Organizational Affiliation
Sterling Research Group, Ltd
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evan Stein, MD
Organizational Affiliation
Metabolic and Atherosclerosis Research Center (MARC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philip Toth, MD
Organizational Affiliation
Midwest Institute for Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig Thompson, MD
Organizational Affiliation
Frederick C. Smith Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Glibert Weiner, MD
Organizational Affiliation
Allied Research International/Cetero Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Allied Research International/Cetero Research
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
St. Luke's Lipid and Diabetes Research Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Piedmont Medical Research Associates
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Metabolic and Atherosclerosis Research Center (MARC)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Sterling Research Group, Ltd
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Frederick C. Smith Clinic
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
TriCities Medical Research
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Diazoxide Choline in Hypertriglyceridemia

We'll reach out to this number within 24 hrs