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

Hypertriglyceridemia Clinical Trial

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 Diabetes Mellitus Having Very High Fasting Triglyceride Levels, With Double-Blind Active-Controlled Extension Assessing Safety and Tolerability

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00973271
• Other study ID #: PV011
• Status: Withdrawn
• Phase: Phase 3
• First received: September 5, 2009
• Last updated: August 30, 2016
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: August 2016
• Source: Essentialis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

Fasting triglycerides

• Difference between Visit 3 (7 days prior to Baseline Visit) and Visit 4 (3 days prior to Baseline Visit) = 60% (compared to the higher value of Visit 3 or Visit 4)

• Run-in Triglycerides* = 500 mg/dL and < 1500 mg/dL *Run-in Triglyceride is defined as the average fasting triglycerides for Visit 3 (7 days prior to Baseline Visit) and Visit 4 (3 days prior to Baseline Visit).

Statin use

• Either Statin-naive

• Must not be on statin at Screening and remaining as such during the Run-in/Washout Period and throughout the study

• Or Statin-treated

• Must be receiving a stable and effective dose of statin for = 3 months without significant side effects or intolerance prior to Screening

• Must be willing to switch to 20 mg atorvastatin at the start of the Run-in/Washout Period and continue throughout the study

Medication washout

• All subjects must be willing to undergo washout of all other lipid-lowering medications

Fasting LDL cholesterol

• = l60 mg/dL at both Screening Visit and Visit 4

Glycemic status

• Fasting glucose < 126 mg/dL at Screening Visit

• HbA1c < 6.5% at Screening Visit

EXCLUSION CRITERIA:

Medications: recent, current, anticipated

• Administration of investigational drugs within 1 month prior to Screening Visit

• Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)

• Thiazide diuretics within 2 weeks prior to Screening Visit

• Discontinuation of beta-blockers within 1 month prior to Screening Visit or planned discontinuation of beta-blocker therapy

• Anticipated requirement for use of prohibited concomitant medications

History of allergic reaction or significant intolerance to:

• Diazoxide

• Thiazides

• Sulfonamides

• Fenofibrate or fenofibric acid derivatives

Lifestyle changes

• Subjects intending to change exercise habits, quit smoking and/or quit alcohol use during the initial 12-week Placebo-Controlled Treatment Period of the study

Specific diagnoses, medical conditions and history

• Known type I or III hyperlipidemia

• Known type 1 DM

• Known type 2 DM

• Any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the study medications, according to the Investigator

Specific laboratory test results

• Any relevant biochemical abnormality interfering with the assessments of the study medications

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• 290 mg DCCR
290 mg diazoxide choline
• 435 mg DCCR
435 mg diazoxide choline
• 135 mg fenofibric acid
135 mg fenofibric acid
• Placebo
Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
• atorvastatin
20 mg atorvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Essentialis, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of DCCR on triglycerides in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days		84 days	No
Secondary	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		84 days	No