Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
3000
Trial Sponsor
Clinical Trial Start Date
2024
0Primary Completion Date
2026
0Study Completion Date
2026
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Interventional Trial Phase
Phase 30
Official Name
Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozsiran in Adults With Severe Hypertriglyceridemia0
Last Updated
April 4, 2024
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Quadruple0
Masked Party
Investigator0
Outcomes Assessor0
Care Provider0
Participant0
Other attributes
Intervention Treatment
Placebo0
Plozasiran Injection0
Study summary
This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After Month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol.
Timeline
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Further Resources
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