Aventiv Research | Aventiv Research Columbus
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About
The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.
Full description
This is a multi-center, randomized, double-blind, placebo-controlled study in up to approximately 540 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.
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Key Inclusion Criteria:
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Primary purpose
Allocation
Interventional model
Masking
617 participants in 2 patient groups, including a placebo group
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Central trial contact
Ionis Pharmaceuticals
Data sourced from clinicaltrials.gov
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