Diazoxide Choline in Hypertriglyceridemia

Summary

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.

Conditions

• Hypertriglyceridemia

Interventions

DRUG

Diazoxide choline

DRUG

Diazoxide choline

DRUG

Diazoxide choline

DRUG

Placebo

Sponsors & Collaborators

• Medpace, Inc.

  collaborator INDUSTRY

• Essentialis, Inc.

  lead INDUSTRY

Principal Investigators

• Harold Bays, MD · L-MARC Research Center

• Alan Forker, MD · St. Luke's Lipid and Diabetes Research Center

• Cynthia Huffman, MD · Meridien Research

• Michael Koren, MD · Jacksonville Center For Clinical Research

• Andrew Lewin, MD · National Research Institute

• Thomas Littlejohn, MD · Piedmont Medical Research Associates

• David Morin, MD · TriCities Medical Research

• Eli Roth, MD · Sterling Research Group, Ltd

• Evan Stein, MD · Metabolic and Atherosclerosis Research Center (MARC)

• Philip Toth, MD · Midwest Institute for Clinical Research

• Craig Thompson, MD · Frederick C. Smith Clinic

• Glibert Weiner, MD · Allied Research International/Cetero Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-06-30

Primary Completion

2009-01-31

Completion

2009-03-31

Countries

• United States

Study Locations