Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia

Study Overview
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Brief Summary
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The primary objective is to determine the efficacy of AKR963 compared to placebo and active comparator in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 1500 mg/dL.

Detailed Description
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Increases in triglyceride concentrations have been correlated with increased risk for pancreatitis as well as for coronary heart disease (Ginsberg 2001, 2002). The incidence rates for major coronary events in the Munster Heart Study increased from 4.4% among Subjects with baseline TG concentrations under 200 mg/dL to 9.3% among Subjects with TG concentrations in the 200-399 mg/dL range, and up to 13.2% in Subjects with TG levels ranging from 400-799 mg/dL (Assmann 1996).

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Study to Assess Efficacy and Safety of AKR-963 Therapy in Subjects With Severe Hypertriglyceridemia

Conditions
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Severe Hypertriglyceridemia

Intervention / Treatment
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* Drug: AKR-963


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, ages 18-79 Fasting triglyceride ≥500 mg/dL and ≤1500 mg/dL Provide written informed consent and authorization for protected health information disclosure Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant Use of non-statin lipid-altering drugs which cannot be stopped or other supplements with potential lipid-altering effects History of pancreatitis History of bariatric surgery or currently on weight loss drugs or in weight loss programs Treatment with any agent that may affect lipid levels or hepatic function Consumption of more than 3 alcoholic beverages per day History of cancer within last 2 years Participation in another clinical trial involving an investigational agent in the last 30 days Other parameters will be assessed at the study center to ensure eligibility for this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator<br>Active comparator | Drug: AKR-963<br>* 3600mg/day in capsules of AKR-963, Placebo, or Active Comparator<br>|
| Placebo Comparator: Placebo<br>Placebo control | Drug: AKR-963<br>* 3600mg/day in capsules of AKR-963, Placebo, or Active Comparator<br>|
| Experimental: AKR-963<br>Investigational drug | Drug: AKR-963<br>* 3600mg/day in capsules of AKR-963, Placebo, or Active Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between AKR963 and Control [placebo or active control] treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ] | The percent change in TG levels from baseline (average of Weeks -2, -1, and 0) to the end of Period A, first 12-week double-blind treatment, (average of Weeks 11 and 12). | 12 weeks |