Diazoxide Choline in Hypertriglyceridemia

Overview

Hypertriglyceridemia affects 30% of the population in the US. Very high level of triglycerides is a known risk factor for pancreatitis. In addition, studies have shown that hypertriglyceridemia is an independent risk factor for cardiovascular disease. Diazoxide is a KATP channel opener. It has been approved by the FDA as an oral suspension for the treatment of hyperinsulinemic hypoglycemic conditions and as an IV solution for malignant hypertension. Preclinical and clinical studies suggest that diazoxide can be a potential therapeutic agent for hypertriglyceridemia. Diazoxide choline is a novel, highly crystalline proprietary salt of diazoxide, which has been formulated as a controlled-release tablet suitable for once per day dosing. This current study is designed to assess the effect of diazoxide choline on triglycerides in subjects with baseline hypertriglyceridemia. In addition, the effects on other lipid parameters, glucose and insulin, body weight as well as the safety and tolerability of diazoxide choline will be assessed.

Full Title of Study: “A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Diazoxide Choline in Non-Diabetic Hypertriglyceridemic Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2009

Interventions

  • Drug: Diazoxide choline
  • Drug: Diazoxide choline
  • Drug: Diazoxide choline
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: 1
    • Diazoxide equivalent dose
  • Experimental: 2
    • Diazoxide equivalent dose
  • Experimental: 3
    • Diazoxide equivalent dose
  • Placebo Comparator: 4

Clinical Trial Outcome Measures

Primary Measures

  • To assess the effect on triglycerides of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects
    • Time Frame: 8 weeks

Secondary Measures

  • To assess the effect on other lipid parameters (LDL, HDL, VLDL, and non-HDL cholesterol), insulin, glucose and weight of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects
    • Time Frame: 8 weeks
  • To assess the safety and tolerability of repeated doses of Diazoxide Choline Controlled-Release Tablet over a period of 56 days in hypertriglyceridemic subjects
    • Time Frame: 8 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • triglycerides ≥ 250 mg/dL and < 600 mg/dL – BMI between 18.5 and 45 – Signed informed consent form Exclusion Criteria:

  • Fasting glucose ≥ 126 mg/dL – Glycosylated hemoglobin (HbA1c) > 6.5% – LDL cholesterol > 190 mg/dL – Known history of type I and II DM – Known history of type I and III hyperlipidemia – Weight change > 3 kg between screening and baseline visits – Pregnancy or intention to become pregnant – Presence of significant underlying conditions that may interfere with the assessments of the study drug

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Essentialis, Inc.
  • Collaborator
    • Medpace, Inc.
  • Provider of Information About this Clinical Study
    • Neil M Cowen, PhD/Chief Scientific Officer, Essentialis
  • Overall Official(s)
    • Harold Bays, MD, Principal Investigator, L-MARC Research Center
    • Alan Forker, MD, Principal Investigator, St. Luke’s Lipid and Diabetes Research Center
    • Cynthia Huffman, MD, Principal Investigator, Meridien Research
    • Michael Koren, MD, Principal Investigator, Jacksonville Center For Clinical Research
    • Andrew Lewin, MD, Principal Investigator, National Research Institute
    • Thomas Littlejohn, MD, Principal Investigator, Piedmont Medical Research Associates
    • David Morin, MD, Principal Investigator, TriCities Medical Research
    • Eli Roth, MD, Principal Investigator, Sterling Research Group, Ltd
    • Evan Stein, MD, Principal Investigator, Metabolic and Atherosclerosis Research Center (MARC)
    • Philip Toth, MD, Principal Investigator, Midwest Institute for Clinical Research
    • Craig Thompson, MD, Principal Investigator, Frederick C. Smith Clinic
    • Glibert Weiner, MD, Principal Investigator, Allied Research International/Cetero Research

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