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This study is researching an experimental drug called ALN-APOC3 (called "study drug"). The study is focused on participants who have dyslipidemia (abnormal amounts of fats in the blood, including triglycerides and cholesterol), but who are otherwise healthy.
The aim of the study is to see how safe and effective the study drug is.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALN-APOC3 Ascending Cohorts | Experimental | Part A: Ascending Cohorts Randomized as described in the protocol May include optional cohorts |
|
| Placebo | Placebo Comparator | Part A and Part B: Randomized as described in the protocol |
|
| ALN-APOC3 low-dose | Experimental | Part B: Parallel Arm Randomized as described in the protocol |
|
| ALN-APOC3 medium-dose | Experimental | Part B: Parallel Arm Randomized as described in the protocol |
|
| ALN-APOC3 high-dose | Experimental | Part B: Parallel Arm Randomized as described in the protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-APOC3 | Drug | Administered as per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Through Week 44 | |
| Severity of TEAEs | Through Week 44 | |
| Percent changes in fasting concentrations of High-Density Lipoprotein Cholesterol (HDL-C) | Part B Only | Baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of combined ALN-APOC3 and metabolites in plasma | Through Week 44 | |
| Urinary excretion of combined ALN-APOC3 and metabolites | Part A Only | Through 24 Hours, After Treatment |
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Key Inclusion Criteria:
Judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECG's) and laboratory safety testing, as defined in the protocol
Participants can enter the study under one of the following options, as defined in the protocol:
Fasting triglycerides concentrations ≥100 and <500 mg/dL (1.13 to 5.65 mmol/L) during screening visit, as defined in the protocol
Fasting LDL-C ≥70 (1.81 mmol/L) if on stable statin therapy OR if not on statin treatment, as defined in the protocol
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arensia Exploratory Medicine at the Republican Clinical Hospital | Chisinau | 2025 | Moldova |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Part A: Sequential Part B: Parallel
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| Matching Placebo | Drug | Administered as per the protocol |
|
| Percent change in fasting concentrations of APOC3 | Baseline to Week 12 |
| Absolute change in fasting concentrations of APOC3 | Baseline to Week 12 |
| Percent change in fasting concentrations of APOC3 | Part B Only | Baseline to Week 24 |
| Absolute change in fasting concentrations of APOC3 | Part B Only | Baseline to Week 24 |
| Percent change in fasting concentrations of HDL-C | Baseline to Week 12 |
| Absolute change in fasting concentrations of HDL-C | Baseline to Week 12 |
| Absolute change in fasting concentrations of HDL-C | Part B Only | Baseline to Week 24 |
| Percent change in fasting concentrations of Low-Density Lipoprotein Cholesterol (LDL-C) | Baseline to Week 12 |
| Absolute change in fasting concentrations of LDL-C | Baseline to Week 12 |
| Percent change in fasting concentrations of LDL-C | Part B Only | Baseline to Week 24 |
| Absolute change in fasting concentrations of LDL-C | Part B Only | Baseline to Week 24 |
| Percent change in fasting concentrations of Triglycerides (TG) | Baseline to Week 12 |
| Absolute change in fasting concentrations of TG | Baseline to Week 12 |
| Percent change in fasting concentrations of TG | Part B Only | Baseline to Week 24 |
| Absolute change in fasting concentrations of TG | Part B Only | Baseline to Week 24 |
| Percent change in fasting concentrations of non-HDL-C | Baseline to Week 12 |
| Absolute change in fasting concentrations of non-HDL-C | Baseline to Week 12 |
| Percent change in fasting concentrations of non-HDL-C | Part B Only | Baseline to Week 24 |
| Absolute change in fasting concentrations of non-HDL-C | Part B Only | Baseline to Week 24 |
| Percent change in fasting concentrations of Apolipoprotein-B (APOB) | Baseline to Week 12 |
| Absolute change in fasting concentrations of APOB | Baseline to Week 12 |
| Percent change in fasting concentrations of APOB | Part B Only | Baseline to Week 24 |
| Absolute change in fasting concentrations of APOB | Part B Only | Baseline to Week 24 |