Clinical Trial: Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Study Assessing the Efficacy, Safety and Tolerability of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects Without

Brief Summary: The hypothesis of this study is that DCCR is effective as both monotherapy and in combination with a statin in lowering triglycerides in subjects with very high triglycerides

Detailed Summary: Very high triglyceride is a risk for pancreatitis. Studies have shown Diazoxide Choline has the potential to effectively lower triglycerides in patients with very high triglycerides.
Sponsor: Essentialis, Inc.

Current Primary Outcome: The effect of DCCR on triglycerides in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days [ Time Frame: 84 days ]

Original Primary Outcome: to assess the effect of DCCR on fasting triglyceride levels over a period of 84 days in subjects without diabetes mellitus who have very high fasting triglyceride levels [ Time Frame: 84 days ]

Current Secondary Outcome: The effects of DCCR on Apo B and non-HDL in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days [ Time Frame: 84 days ]

Original Secondary Outcome:

Information By: Essentialis, Inc.

Dates:
Date Received: September 5, 2009
Date Started: March 2011
Date Completion:
Last Updated: August 30, 2016
Last Verified: August 2016