Status:
COMPLETED
Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia
Lead Sponsor:
Essentialis, Inc.
Collaborating Sponsors:
Medpace, Inc.
Conditions:
Hypertriglyceridemia
Dyslipidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 b...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01211847
Start Date
October 1 2010
End Date
December 1 2011
Last Update
January 10 2014
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