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NCT Number: NCT00696475

Diazoxide Choline in Hypertriglyceridemia

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.

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Research Institute, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diazoxide choline

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Essentialis, Inc.

Industry

Collaborators

  • Medpace, Inc.

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 12, 2008
Registry last updated
Nov 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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