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This study is researching an experimental drug called ALN-ANG3 (called "study drug"). The study is focused on healthy participants with an elevated level of blood lipids (eg, cholesterol and triglycerides).
The aim of the study is to see how safe and tolerable the study drug is in healthy adult participants.
The study is looking at several other research questions, including:
This is a 2-Part study. Participants in Part A are excluded from participation in Part B
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Cohorts | Experimental |
| |
| Part B: Cohorts | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-ANG3 | Drug | Administered per the protocol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | In participants treated with ALN-ANG3 or placebo (PBO) | Up to Approximately 323 Days |
| Severity of TEAEs | In participants treated with ALN-ANG3 or PBO | Up to Approximately 323 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of combined ALN-ANG3 and its (N-1)3^1 metabolite in plasma | Part A | Within 3 Days Post Dose up to Approximately 323 Days |
| Concentration of combined ALN-ANG3 and its (N-1)3^1 metabolite in plasma |
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Key Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| New Zealand Clinical Research | Christchurch | Canterbury | 8013 | New Zealand |
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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| Placebo (PB) |
| Drug |
Administered per the protocol |
|
Part B
| Prior to Each Dose up to Approximately 323 Days |