Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01211847
Recruitment Status : Completed
First Posted : September 30, 2010
Last Update Posted : January 10, 2014
Medpace, Inc.
Information provided by (Responsible Party):
Essentialis, Inc.

Brief Summary:
Once a day oral administration with DCCR helps lower triglycerides

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Dyslipidemia Drug: Diazoxide Choline Controlled-Release Tablet Drug: Placebo Phase 2

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,

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : October 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Triglyceride-lowering efficacy of DCCR [ Time Frame: 84 days ]
    Fasting triglycerides (percent change from Baseline to Day 84)

Secondary Outcome Measures :
  1. Improvement in other lipid profiles with DCCR [ Time Frame: 84 days ]
    Apolipoprotein B (Apo B) (percent change from Baseline to Day 84) Fasting non-HDL cholesterol (percent change from Baseline to Day 84)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01211847

Sponsors and Collaborators
Essentialis, Inc.
Medpace, Inc.
Study Director: Alain Baron, M.D. Essentialis, Inc.

Responsible Party: Essentialis, Inc. Identifier: NCT01211847     History of Changes
Other Study ID Numbers: CT013
First Posted: September 30, 2010    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014

Keywords provided by Essentialis, Inc.:
Apo B

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Lipotropic Agents
Gastrointestinal Agents
Nootropic Agents
Antihypertensive Agents
Vasodilator Agents