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Study of Plozasiran (ARO-APOC3) in Adults With Mixed Dyslipidemia
Sponsor: Arrowhead Pharmaceuticals
Summary
Participants who have met all protocol eligibility criteria will be randomly assigned to treatment (ARO-APOC3 or placebo) in a double-blind fashion and will be evaluated for safety and efficacy over 48 weeks. Participants will be counseled to remain on a specified diet throughout the study, as recommended by the Investigator in accordance with local standards of care. After week 48, participants will be eligible and invited to consent and continue in an open-label extension study. All placebo participants who opt to continue will switch to active drug (ARO-APOC3) during the extension study.
Official title: A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Mixed Dyslipidemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
353
Start Date
2021-09-28
Completion Date
2023-08-14
Last Updated
2026-04-14
Healthy Volunteers
No
Conditions
Interventions
ARO-APOC3
ARO-APOC3 Injection
Placebo
Sterile Normal Saline (0.9% NaCl)
Locations (30)
Research Site 3
Beverly Hills, California, United States
Research Site 8
Northridge, California, United States
Research Site 2
Boca Raton, Florida, United States
Research Site 1
Fort Lauderdale, Florida, United States
Research Site 14
Miami Springs, Florida, United States
Research Site 5
Pembroke Pines, Florida, United States
Research Site 18
Dunwoody, Georgia, United States
Research Site 31
Las Vegas, Nevada, United States
Research Site 17
New Windsor, New York, United States
Research Site 12
Dayton, Ohio, United States
Research Site 4
Franklin, Ohio, United States
Research Site 7
Greenville, South Carolina, United States
Research Site 6
Houston, Texas, United States
Research Site 32
Houston, Texas, United States
Research Site 13
San Antonio, Texas, United States
Research Site 30
Morayfield, Queensland, Australia
Research Site 29
Adelaide, South Australia, Australia
Research Site 19
Clayton, Victoria, Australia
Research Site 27
Joondalup, Western Australia, Australia
Research Site 15
Concord, Ontario, Canada
Research Site 10
Montreal, Quebec, Canada
Research Site 20
Balatonfüred, Hungary
Research Site 21
Debrecen, Hungary
Research Site 22
Nyíregyháza, Hungary
Research Site 11
Auckland, New Zealand
Research Site 16
Christchurch, New Zealand
Research Site 28
Lodz, Poland
Research Site 24
Lodz, Poland
Research Site 25
Poznan, Poland
Research Site 26
Rzeszów, Poland