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Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia

Primary Purpose

Hypertriglyceridemia, Dyslipidemia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Diazoxide Choline Controlled-Release Tablet
Placebo
Sponsored by
Essentialis, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring triglycerides, Apo B, non-HDL, statin, fenofibrate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    DCCR

    Placebo

    Arm Description

    DCCR Treatment with 290 mg Diazoxide Choline

    Placebo matching DCCR

    Outcomes

    Primary Outcome Measures

    Triglyceride-lowering efficacy of DCCR
    Fasting triglycerides (percent change from Baseline to Day 84)

    Secondary Outcome Measures

    Improvement in other lipid profiles with DCCR
    Apolipoprotein B (Apo B) (percent change from Baseline to Day 84) Fasting non-HDL cholesterol (percent change from Baseline to Day 84)

    Full Information

    First Posted
    September 29, 2010
    Last Updated
    January 9, 2014
    Sponsor
    Essentialis, Inc.
    Collaborators
    Medpace, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01211847
    Brief Title
    Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2010 (undefined)
    Primary Completion Date
    September 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Essentialis, Inc.
    Collaborators
    Medpace, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertriglyceridemia, Dyslipidemia
    Keywords
    triglycerides, Apo B, non-HDL, statin, fenofibrate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DCCR
    Arm Type
    Experimental
    Arm Description
    DCCR Treatment with 290 mg Diazoxide Choline
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo matching DCCR
    Intervention Type
    Drug
    Intervention Name(s)
    Diazoxide Choline Controlled-Release Tablet
    Intervention Description
    DCCR 290 mg once a day for 126 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo matching DCCR
    Primary Outcome Measure Information:
    Title
    Triglyceride-lowering efficacy of DCCR
    Description
    Fasting triglycerides (percent change from Baseline to Day 84)
    Time Frame
    84 days
    Secondary Outcome Measure Information:
    Title
    Improvement in other lipid profiles with DCCR
    Description
    Apolipoprotein B (Apo B) (percent change from Baseline to Day 84) Fasting non-HDL cholesterol (percent change from Baseline to Day 84)
    Time Frame
    84 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alain Baron, M.D.
    Organizational Affiliation
    Essentialis, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia

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