A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia
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- STATUS
- Recruiting
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- End date
- Jul 19, 2025
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- participants needed
- 390
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- sponsor
- Ionis Pharmaceuticals, Inc.
Summary
The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.
Description
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study in up to approximately 390 participants. Participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. The length of participation in the study will be approximately 78 weeks, which includes an up to 12-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.
The Screening Period was extended with no impact to overall study timelines. Endpoints added to provide assessment on the pancreatitis rate after olezarsen reaches steady state levels.
Details
| Condition | Severe Hypertriglyceridemia |
|---|---|
| Treatment | Placebo, Olezarsen |
| Clinical Study Identifier | NCT05552326 |
| Sponsor | Ionis Pharmaceuticals, Inc. |
| Last Modified on | 19 September 2023 |
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