Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia

This study has been completed.
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Essentialis, Inc.
ClinicalTrials.gov Identifier:
NCT01211847
First received: September 29, 2010
Last updated: January 9, 2014
Last verified: January 2014
  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:


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)


Enrollment: 44
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Essentialis, Inc.
ClinicalTrials.gov Identifier: NCT01211847     History of Changes
Other Study ID Numbers: CT013
Study First Received: September 29, 2010
Last Updated: January 9, 2014
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 August 28, 2014