Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia

NCT01211847 | Completed Phase 2

• 1 other identifier: CT013
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

Once a day oral administration with DCCR helps lower triglycerides

Conditions

Hypertriglyceridemia; Dyslipidemia

Keywords

triglycerides; Apo B; non-HDL; statin; fenofibrate

Outcome Measures

Primary Outcomes (1)

• Triglyceride-lowering efficacy of DCCR

  Fasting triglycerides (percent change from Baseline to Day 84)

  84 days

Secondary Outcomes (1)

• Improvement in other lipid profiles with DCCR

  84 days

Study Arms (2)

DCCR

EXPERIMENTAL

DCCR Treatment with 290 mg Diazoxide Choline

Drug: Diazoxide Choline Controlled-Release Tablet

Placebo

PLACEBO COMPARATOR

Placebo matching DCCR

Drug: Placebo

Interventions

Diazoxide Choline Controlled-Release Tablet DRUG

DCCR 290 mg once a day for 126 days

DCCR

Placebo DRUG

Placebo matching DCCR

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Essentialis, Inc.: lead
• Medpace, Inc.: collaborator

MeSH Terms

Conditions

Hypertriglyceridemia; Dyslipidemias

Condition Hierarchy (Ancestors)

Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alain Baron, M.D.

  Essentialis, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: September 30, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 10, 2014

Record last verified: 2014-01