Diazoxide Choline in Hypertriglyceridemia
This study has been completed.
Sponsor:
Essentialis, Inc.
Collaborator:
Medpace, Inc.
Information provided by:
Essentialis, Inc.
ClinicalTrials.gov Identifier:
NCT00696475
First received: June 10, 2008
Last updated: November 4, 2010
Last verified: November 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertriglyceridemia |
Drug: Diazoxide choline Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Diazoxide Choline in Non-Diabetic Hypertriglyceridemic Subjects |
Resource links provided by NLM:
Further study details as provided by Essentialis, Inc.:
Primary Outcome 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 ] [ Designated as safety issue: No ]
Secondary Outcome 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Diazoxide equivalent dose
|
Drug: Diazoxide choline |
|
Experimental: 2
Diazoxide equivalent dose
|
Drug: Diazoxide choline |
|
Experimental: 3
Diazoxide equivalent dose
|
Drug: Diazoxide choline |
| Placebo Comparator: 4 | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696475
Locations
| United States, California | |
| National Research Institute | |
| Los Angeles, California, United States, 90057 | |
| United States, Florida | |
| Jacksonville Center for Clinical Research | |
| Jacksonville, Florida, United States, 32216 | |
| Allied Research International/Cetero Research | |
| Miami Gardens, Florida, United States, 33169 | |
| Meridien Research | |
| Tampa, Florida, United States, 33606 | |
| United States, Indiana | |
| Midwest Institute for Clinical Research | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kentucky | |
| L-MARC Research Center | |
| Louisville, Kentucky, United States, 40213 | |
| United States, Missouri | |
| St. Luke's Lipid and Diabetes Research Center | |
| Kansas City, Missouri, United States, 64111 | |
| United States, North Carolina | |
| Piedmont Medical Research Associates | |
| Winston Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Sterling Research Group, Ltd | |
| Cincinnati, Ohio, United States, 45219 | |
| Metabolic and Atherosclerosis Research Center (MARC) | |
| Cincinnati, Ohio, United States, 45212 | |
| Frederick C. Smith Clinic | |
| Marion, Ohio, United States, 43302 | |
| United States, Tennessee | |
| TriCities Medical Research | |
| Bristol, Tennessee, United States, 37620 | |
Sponsors and Collaborators
Essentialis, Inc.
Medpace, Inc.
Investigators
| Principal Investigator: | 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 |
More Information
No publications provided
| Responsible Party: | Neil M Cowen, PhD/Chief Scientific Officer, Essentialis |
| ClinicalTrials.gov Identifier: | NCT00696475 History of Changes |
| Other Study ID Numbers: | PC007 |
| Study First Received: | June 10, 2008 |
| Last Updated: | November 4, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypertriglyceridemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Choline Diazoxide Lipotropic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gastrointestinal Agents Therapeutic Uses Lipid Regulating Agents Nootropic Agents Central Nervous System Agents Antihypertensive Agents Cardiovascular Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on May 23, 2013