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Phase Study of Plozasiran in Adults With Severe Hypertriglyceridemia

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Contents

clinicaltrials.gov/study/NCT06347016
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT063470160
Trial Recruitment Size
3000
Trial Sponsor
Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals
0
Clinical Trial Start Date
2024
0
Primary Completion Date
2026
0
Study Completion Date
2026
0
Clinical 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
0
Allocation 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.

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