Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
720
Trial Sponsor
Clinical Trial Start Date
January 11, 2022
0Primary Completion Date
2024
0Study Completion Date
2026
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Intervention Name
ARO-APOC30
Placebo0
Interventional Trial Phase
Phase 30
Participating Facility
Official Name
A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Familial Chylomicronemia Syndrome0
Last Updated
June 12, 2023
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Quadruple0
Masked Party
Participant0
Care Provider0
Investigator0
Outcomes Assessor0
Study summary
The purpose or AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all eligibility criteria will be randomized to receive 4 doses of ARO-APOC3 or matching placebo administered subcutaneously. Participants who complete the randomized period will continue in a 2-year open-label extension period where all participants will receive ARO-APOC3.
Timeline
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