Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2008-06-30
2009-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Diazoxide equivalent dose
Diazoxide choline
2
Diazoxide equivalent dose
Diazoxide choline
3
Diazoxide equivalent dose
Diazoxide choline
4
Placebo
Interventions
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Diazoxide choline
Diazoxide choline
Diazoxide choline
Placebo
Eligibility Criteria
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Inclusion Criteria
* BMI between 18.5 and 45
* Signed informed consent form
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Medpace, Inc.
INDUSTRY
Essentialis, Inc.
INDUSTRY
Responsible Party
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Essentialis
Principal Investigators
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Harold Bays, MD
Role: PRINCIPAL_INVESTIGATOR
L-MARC Research Center
Alan Forker, MD
Role: PRINCIPAL_INVESTIGATOR
St. Luke's Lipid and Diabetes Research Center
Cynthia Huffman, MD
Role: PRINCIPAL_INVESTIGATOR
Meridien Research
Michael Koren, MD
Role: PRINCIPAL_INVESTIGATOR
Jacksonville Center For Clinical Research
Andrew Lewin, MD
Role: PRINCIPAL_INVESTIGATOR
National Research Institute
Thomas Littlejohn, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Medical Research Associates
David Morin, MD
Role: PRINCIPAL_INVESTIGATOR
TriCities Medical Research
Eli Roth, MD
Role: PRINCIPAL_INVESTIGATOR
Sterling Research Group, Ltd
Evan Stein, MD
Role: PRINCIPAL_INVESTIGATOR
Metabolic and Atherosclerosis Research Center (MARC)
Philip Toth, MD
Role: PRINCIPAL_INVESTIGATOR
Midwest Institute for Clinical Research
Craig Thompson, MD
Role: PRINCIPAL_INVESTIGATOR
Frederick C. Smith Clinic
Glibert Weiner, MD
Role: PRINCIPAL_INVESTIGATOR
Allied Research International/Cetero Research
Locations
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National Research Institute
Los Angeles, California, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Allied Research International/Cetero Research
Miami Gardens, Florida, United States
Meridien Research
Tampa, Florida, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States
L-MARC Research Center
Louisville, Kentucky, United States
St. Luke's Lipid and Diabetes Research Center
Kansas City, Missouri, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States
Metabolic and Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, United States
Sterling Research Group, Ltd
Cincinnati, Ohio, United States
Frederick C. Smith Clinic
Marion, Ohio, United States
TriCities Medical Research
Bristol, Tennessee, United States
Countries
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Other Identifiers
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PC007
Identifier Type: -
Identifier Source: org_study_id