Hypertriglyceridemia
Conditions
Keywords
hypertriglyceridemia
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 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.
Interventions
DRUGPlacebo
Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
DRUGatorvastatin
20 mg atorvastatin
DRUG290 mg DCCR
290 mg diazoxide choline
DRUG435 mg DCCR
435 mg diazoxide choline
DRUG135 mg fenofibric acid
135 mg fenofibric acid
Sponsors
Essentialis, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of DCCR on triglycerides in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days | 84 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed