Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia - Full Text View

Sponsor:	Essentialis, Inc.
Collaborator:	Medpace, Inc.
Information provided by:	Essentialis, Inc.
ClinicalTrials.gov Identifier:	NCT01211847

Purpose

Once a day oral administration with DCCR helps lower triglycerides

Condition	Intervention	Phase
Hypertriglyceridemia Dyslipidemia	Drug: Diazoxide Choline Controlled-Release Tablet Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects Without Diabetes Mellitus Having Very High Fasting Triglyceride Levels, With Double-Blind DCCR-Fenofibrate Combination Extension

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Triglycerides

Drug Information available for: Choline bitartrate Diazoxide Fenofibrate

U.S. FDA Resources

Further study details as provided by Essentialis, Inc.:

Primary Outcome Measures:

Triglyceride-lowering efficacy of DCCR [ Time Frame: 84 days ] [ Designated as safety issue: No ]
Fasting triglycerides (percent change from Baseline to Day 84)

Secondary Outcome Measures:

Improvement in other lipid profiles with DCCR [ Time Frame: 84 days ] [ Designated as safety issue: No ]
Apolipoprotein B (Apo B) (percent change from Baseline to Day 84) Fasting non-HDL cholesterol (percent change from Baseline to Day 84)

Estimated Enrollment:	44
Study Start Date:	October 2010
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: DCCR DCCR Treatment with 290 mg Diazoxide Choline	Drug: Diazoxide Choline Controlled-Release Tablet DCCR 290 mg once a day for 126 days
Placebo Comparator: Placebo Placebo matching DCCR	Drug: Placebo Placebo matching DCCR

Detailed Description:

The population will consist of Statin-naive and Statin-treated subjects, all without diabetes mellitus, with fasting triglyceride levels in the range of ≥ 500 mg/dL and < 1500 mg/dL.

Subjects will be randomly assigned to 1 of 2 treatment groups: DCCR and Placebo

Approximately 44 subjects will be enrolled in the study and stratified by Statin use at a 1:1 ratio in each treatment group,

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

INCLUSION CRITERIA:

Fasting triglycerides

Difference between Visit 3 (7 days prior to Baseline Visit) and Visit 4 (3 days prior to Baseline Visit) ≤ 60% (compared to the higher value of Visit 3 or Visit 4)
Run-in Triglycerides* ≥ 500 mg/dL and < 1500 mg/dL *Run-in Triglyceride is defined as the average fasting triglycerides for Visit 3 (7 days prior to Baseline Visit) and Visit 4 (3 days prior to Baseline Visit).

Statin use • Either Statin-naive

Must not be on statin at Screening and remaining as such during the Run-in/Washout Period and throughout the study

• Or Statin-treated
Must be on Lipitor 20 mg initiated at the start of the Run-in/Washout Period and continue throughout the study

Medication washout

All subjects must be willing to undergo washout of all other lipid-lowering medications

Glycemic status

Fasting glucose < 126 mg/dL at Screening Visit
HbA1c < 6.5% at Screening Visit

EXCLUSION CRITERIA:

Medications: recent, current, anticipated

Administration of investigational drugs within 1 month prior to Screening Visit
Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)
Thiazide diuretics within 2 weeks prior to Screening Visit
Discontinuation of beta-blockers within 1 month prior to Screening Visit or planned discontinuation of beta-blocker therapy
Anticipated requirement for use of prohibited concomitant medications

History of allergic reaction or significant intolerance to:

Diazoxide
Thiazides
Sulfonamides
Fenofibrate or fenofibric acid derivatives

Lifestyle changes

• Subjects intending to change exercise habits, quit smoking and/or quit alcohol use during the entire study

Specific diagnoses, medical conditions and history

Known type I or III hyperlipidemia
Known type 1 DM
Current diagnosis of type 2 DM
Any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the study medications, according to the Investigator

Specific laboratory test results

• Any relevant biochemical abnormality interfering with the assessments of the study medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211847

Sponsors and Collaborators

Essentialis, Inc.

Medpace, Inc.

Investigators

Study Director:

Alain Baron, M.D.

Essentialis, Inc.

More Information

No publications provided

Responsible Party:	Neil M Cowen, PhD/Chief Scientific Officer, Essentialis, Inc.
ClinicalTrials.gov Identifier:	NCT01211847 History of Changes
Other Study ID Numbers:	CT013
Study First Received:	September 29, 2010
Last Updated:	August 16, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Essentialis, Inc.:

triglycerides
Apo B
non-HDL
statin
fenofibrate

Additional relevant MeSH terms:

Hypertriglyceridemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Choline
Fenofibrate
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 May 24, 2012