Diazoxide Choline in Hypertriglyceridemia

NCT00696475 | Completed Phase 2

• 1 other identifier: PC007
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 12

Brief 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

Outcome Measures

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

  8 weeks

Secondary Outcomes (2)

• 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

  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

  8 weeks

Study Arms (4)

1

EXPERIMENTAL

Diazoxide equivalent dose

Drug: Diazoxide choline

2

EXPERIMENTAL

Diazoxide equivalent dose

Drug: Diazoxide choline

3

EXPERIMENTAL

Diazoxide equivalent dose

Drug: Diazoxide choline

4

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Diazoxide choline DRUG

1

Placebo DRUG

4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• triglycerides ≥ 250 mg/dL and \< 600 mg/dL
• BMI between 18.5 and 45
• Signed informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Essentialis, Inc.: lead
• Medpace, Inc.: collaborator

Study Sites (12)

National Research Institute

Los Angeles, California, 90057, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Allied Research International/Cetero Research

Miami Gardens, Florida, 33169, United States

Location

Meridien Research

Tampa, Florida, 33606, United States

Location

Midwest Institute for Clinical Research

Indianapolis, Indiana, 46260, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

St. Luke's Lipid and Diabetes Research Center

Kansas City, Missouri, 64111, United States

Location

Piedmont Medical Research Associates

Winston-Salem, North Carolina, 27103, United States

Location

Metabolic and Atherosclerosis Research Center (MARC)

Cincinnati, Ohio, 45212, United States

Location

Sterling Research Group, Ltd

Cincinnati, Ohio, 45219, United States

Location

Frederick C. Smith Clinic

Marion, Ohio, 43302, United States

Location

TriCities Medical Research

Bristol, Tennessee, 37620, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Harold Bays, MD

  L-MARC Research Center

  PRINCIPAL INVESTIGATOR

• Alan Forker, MD

  St. Luke's Lipid and Diabetes Research Center

  PRINCIPAL INVESTIGATOR

• Cynthia Huffman, MD

  Meridien Research

  PRINCIPAL INVESTIGATOR

• Michael Koren, MD

  Jacksonville Center For Clinical Research

  PRINCIPAL INVESTIGATOR

• Andrew Lewin, MD

  National Research Institute

  PRINCIPAL INVESTIGATOR

• Thomas Littlejohn, MD

  Piedmont Medical Research Associates

  PRINCIPAL INVESTIGATOR

• David Morin, MD

  TriCities Medical Research

  PRINCIPAL INVESTIGATOR

• Eli Roth, MD

  Sterling Research Group, Ltd

  PRINCIPAL INVESTIGATOR

• Evan Stein, MD

  Metabolic and Atherosclerosis Research Center (MARC)

  PRINCIPAL INVESTIGATOR

• Philip Toth, MD

  Midwest Institute for Clinical Research

  PRINCIPAL INVESTIGATOR

• Craig Thompson, MD

  Frederick C. Smith Clinic

  PRINCIPAL INVESTIGATOR

• Glibert Weiner, MD

  Allied Research International/Cetero Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 12, 2008
• Study Start: June 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 8, 2010

Record last verified: 2010-11

Locations

US (12)