AZD0585 Phase III Long-term Study in Japan

Study Overview
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Brief Summary
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This study is a randomised, double-blind phase III long-term study to evaluate efficacy and safety of 12 weeks and 52 weeks of AZD0585 administration compared to placebo in patients with hyperlipidemia accompanied by hypertriglyceridemia .

Official Title
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A Randomised, Double-blind, Placebo Controlled, Parallel Group, Phase III Long-term Study to Evaluate Efficacy and Safety of 12 Weeks and 52 Weeks of AZD0585 Administration, Respectively, in Japanese Patients With Hyperlipidemia Accompanied by Hypertriglyceridemia.

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: AZD0585
* Drug: AZD0585 placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Japanese men or women, ≥20 years of age. Subjects must meet all of the following criteria; Fasting triglyceride level: average of Visit 2 and Visit 3 must be in the range 150 - 499 mg/dL %TG change between Visit 2 and Visit 3 must be within 30% %LDL-C change between Visit 2 and Visit 3 must be within 25% Key Exclusion Criteria: Allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters. Known lipoprotein lipase impairment or deficiency, or Apolipoprotein C-II deficiency or familial dysbetalipoproteinemia. Current or history of pancreatitis. Type I diabetes mellitus, use of insulin, or haemoglobin A1c >10% at Visit 1.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 130 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD0585 2g group<br>AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily | Drug: AZD0585<br>* 1g soft capsule<br>* Other names: Epanova;Drug: AZD0585 placebo<br>* 1g soft capsule<br>* Other names: Corn oil;|
| Experimental: AZD0585 4g group<br>AZD0585 1g × 4 capsules once daily | Drug: AZD0585<br>* 1g soft capsule<br>* Other names: Epanova;|
| Placebo Comparator: Placebo control group<br>AZD0585 placebo 1g × 4 capsules once daily | Drug: AZD0585 placebo<br>* 1g soft capsule<br>* Other names: Corn oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides | To demonstrate the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) in Japanese patients with hypertriglyceridemia. | From baseline to Week12 | 
| Safety of AZD0585 by Assessment of Adverse Events in Patients | To evaluate the long-term (up to 52 weeks) safety of AZD0585 in Japanese patients with hypertriglyceridemia. | From baseline to Week52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil). The serum lipid profile includes total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol,Very low-density lipoprotein cholesterol and Non-high-density lipoprotein cholesterol. | From baseline to Week12 | 
| Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile. | To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) . The plasma fatty acids profile includes eicosapentaenoic acid, docosahexaenoic acid, arachidonic acid and eicosapentaenoic acid per arachidonic acid rate. | From baseline to Week12 | 
| Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) . Apolipoproteins include Apolipoprotein A-I, Apolipoprotein A-II, Apolipoprotein B, Apolipoprotein B48, Apolipoprotein C-II, Apolipoprotein C-III and Apolipoprotein E. | From baseline to Week12 | 
| Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio | To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil). | From baseline to Week12 | 
| Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP | To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil). | From baseline to Week12 |