Study of ARO-APOC3 in Adults With Dyslipidemia

Study Overview
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Brief Summary
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This is an open-label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002. Adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continue to meet eligibility criteria have the option to be enrolled into this study. Eligible enrolled participants will initially receive open-label ARO-APOC3 at the assigned dose level until a final dose is selected, at which point all participants will be transitioned to the selected dosing regimen.

Official Title
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A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults With Dyslipidemia

Conditions
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Dyslipidemias

Intervention / Treatment
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* Drug: ARO-APOC3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults who are nonpregnant, nonlactating and do not plan to become pregnant during the study Able and willing to provide written informed consent Completed the 48-week study treatment period in the parent study Exclusion Criteria: Subject was permanently discontinued from ARO-APOC3 in the parent study due to elevated glycated hemoglobin (HbA1c), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) Any new condition or worsening of existing condition or any other situation that would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements or put the subject at additional safety risk Unwilling to limit alcohol consumption to within moderate limits for the duration of the study

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARO-APOC3<br>1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 or 6 months | Drug: ARO-APOC3<br>* ARO-APOC3 Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) |  | Through 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Fasting Triglycerides (TG) Over Time |  | Through 24 months | 
| Percent Change from Baseline in Fasting TG Over Time |  | Through 24 months | 
| Change from Baseline in Apolipoprotein (Apo) C-III Over Time |  | Through 24 months | 
| Percent Change from Baseline in ApoC-III Over Time |  | Through 24 months | 
| Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Over Time |  | Through 24 months | 
| Percent Change from Baseline in Fasting Non-HDL-C Over Time |  | Through 24 months | 
| Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time |  | Through 24 months | 
| Percent Change from Baseline in Fasting HDL-C Over Time |  | Through 24 months | 
| Change from Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time |  | Through 24 months | 
| Percent Change from Baseline in Fasting Total ApoB Over Time |  | Through 24 months | 
| Change from Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) Over Time Using Ultracentrifugation |  | Through 24 months | 
| Percent Change from Baseline in Fasting LDL-C Over Time Using Ultracentrifugation |  | Through 24 months |