Dyslipidemia, Hypertriglyceridemia
Conditions
Keywords
triglycerides, Apo B, non-HDL, statin, fenofibrate
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 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,
Interventions
DCCR 290 mg once a day for 126 days
DRUGPlacebo
Placebo matching DCCR
Sponsors
Medpace, Inc.
Essentialis, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Triglyceride-lowering efficacy of DCCR | 84 days | Fasting triglycerides (percent change from Baseline to Day 84) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in other lipid profiles with DCCR | 84 days | Apolipoprotein B (Apo B) (percent change from Baseline to Day 84) Fasting non-HDL cholesterol (percent change from Baseline to Day 84) |
Outcome results
None listed