NCT01211847

Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects Without Diabetes Mellitus Having Very High Fasting Triglyceride Levels, With Double-Blind DCCR-Fenofibrate Combination Extension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Essentialis, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Once a day oral administration with DCCR helps lower triglycerides

Detailed description

The population will consist of Statin-naive and Statin-treated subjects, all without diabetes mellitus, with fasting triglyceride levels in the range of ≥ 500 mg/dL and \< 1500 mg/dL. Subjects will be randomly assigned to 1 of 2 treatment groups: DCCR and Placebo Approximately 44 subjects will be enrolled in the study and stratified by Statin use at a 1:1 ratio in each treatment group,

Conditions

• Hypertriglyceridemia
• Dyslipidemia

Interventions

Type	Name	Description
DRUG	Diazoxide Choline Controlled-Release Tablet	DCCR 290 mg once a day for 126 days
DRUG	Placebo	Placebo matching DCCR

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-09-01
• Completion: 2011-12-01
• First posted: 2010-09-30
• Last updated: 2014-01-10