Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia

Phase 2

Completed

• Conditions: Hypertriglyceridemia; Dyslipidemia
• Interventions: Drug: Placebo; Drug: Diazoxide Choline Controlled-Release Tablet

• Registration Number: NCT01211847
• Lead Sponsor: Essentialis, Inc.

Brief 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,

Study Timeline

• Study First Submitted: 2010-09-29
• Study First Submitted QC: 2010-09-29
• Study First Posted: 2010-09-30
• Study Start: 2010-10
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo matching DCCR
DCCR	Diazoxide Choline Controlled-Release Tablet	DCCR Treatment with 290 mg Diazoxide Choline

Primary Outcome Measures

Name	Time	Method
Triglyceride-lowering efficacy of DCCR	84 days	Fasting triglycerides (percent change from Baseline to Day 84)

Secondary Outcome Measures

Name	Time	Method
Improvement in other lipid profiles with DCCR	84 days	Apolipoprotein B (Apo B) (percent change from Baseline to Day 84) Fasting non-HDL cholesterol (percent change from Baseline to Day 84)