Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211847
• Other study ID #: CT013
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2010
• Last updated: January 9, 2014
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2014
• Source: Essentialis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Once a day oral administration with DCCR helps lower triglycerides

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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 on Lipitor 20 mg initiated 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

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 entire study

Specific diagnoses, medical conditions and history

• Known type I or III hyperlipidemia

• Known type 1 DM

• Current diagnosis of 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, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertriglyceridemia

Intervention

Drug:
• Diazoxide Choline Controlled-Release Tablet
DCCR 290 mg once a day for 126 days
• Placebo
Placebo matching DCCR

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Essentialis, Inc.	Medpace, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triglyceride-lowering efficacy of DCCR	Fasting triglycerides (percent change from Baseline to Day 84)	84 days	No
Secondary	Improvement in other lipid profiles with DCCR	Apolipoprotein B (Apo B) (percent change from Baseline to Day 84) Fasting non-HDL cholesterol (percent change from Baseline to Day 84)	84 days	No