Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides - Full Text View

Sponsor:	Essentialis, Inc.
Information provided by:	Essentialis, Inc.
ClinicalTrials.gov Identifier:	NCT00973271

Purpose

The hypothesis of this study is that DCCR is effective as both monotherapy and in combination with a statin in lowering triglycerides in subjects with very high triglycerides

Condition	Intervention	Phase
Hypertriglyceridemia	Drug: 290 mg DCCR Drug: 435 mg DCCR Drug: 135 mg fenofibric acid Drug: Placebo Drug: atorvastatin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multi-Center, Randomized, Double-Blind, Placebo- and Active-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 Active-Controlled Extension Assessing Safety and Tolerability

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 Choline chloride Choline dihydrogen citrate Choline bitartrate Atorvastatin Atorvastatin calcium Diazoxide Choline salicylate

U.S. FDA Resources

Further study details as provided by Essentialis, Inc.:

Primary Outcome Measures:

The effect of DCCR on triglycerides in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days [ Time Frame: 84 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The effects of DCCR on Apo B and non-HDL in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days [ Time Frame: 84 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	750
Study Start Date:	March 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 290 mg DCCR	Drug: 290 mg DCCR 290 mg diazoxide choline Other Name: 290 mg DCCR Drug: Placebo Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid Other Name: Placebos matching DCCR and fenofibric acid Drug: atorvastatin 20 mg atorvastatin Other Name: 20 mg atorvastatin
Experimental: 435 mg DCCR	Drug: 435 mg DCCR 435 mg diazoxide choline Other Name: 435 mg DCCR Drug: Placebo Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid Other Name: Placebos matching DCCR and fenofibric acid Drug: atorvastatin 20 mg atorvastatin Other Name: 20 mg atorvastatin
Active Comparator: 135 mg fenobric acid	Drug: 135 mg fenofibric acid 135 mg fenofibric acid Other Name: 135 mg fenobric acid Drug: Placebo Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid Other Name: Placebos matching DCCR and fenofibric acid Drug: atorvastatin 20 mg atorvastatin Other Name: 20 mg atorvastatin
Placebo Comparator: Placebo	Drug: Placebo Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid Other Name: Placebos matching DCCR and fenofibric acid Drug: atorvastatin 20 mg atorvastatin Other Name: 20 mg atorvastatin

Detailed Description:

Very high triglyceride is a risk for pancreatitis. Studies have shown Diazoxide Choline has the potential to effectively lower triglycerides in patients with very high triglycerides.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 receiving a stable and effective dose of statin for ≥ 3 months without significant side effects or intolerance prior to Screening
- Must be willing to switch to 20 mg atorvastatin 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

Fasting LDL cholesterol

≤ l60 mg/dL at both Screening Visit and Visit 4

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 initial 12-week Placebo-Controlled Treatment Period of the study

Specific diagnoses, medical conditions and history

Known type I or III hyperlipidemia
Known type 1 DM
Known 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: NCT00973271

Contacts

Contact: Gloria C Lin, PhD	858-964-5013	gloria.lin@essentialistherapeutics.com
Contact: Neil M Cowen, PhD	858-964-5008	nmcowen@essentialistherapeutics.com

Sponsors and Collaborators

Essentialis, Inc.

More Information

No publications provided

Responsible Party:	Neil M. Cowen, PhD, Chief Scientific Officer, Essentialis, Inc.
ClinicalTrials.gov Identifier:	NCT00973271 History of Changes
Other Study ID Numbers:	PV011
Study First Received:	September 5, 2009
Last Updated:	November 4, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Essentialis, Inc.:

hypertriglyceridemia

Additional relevant MeSH terms:

Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Choline
Fenofibric acid
Fenofibrate
Atorvastatin
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
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012