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COMPLETED
NCT04998201
PHASE2

Study of Plozasiran (ARO-APOC3) in Adults With Mixed Dyslipidemia

Sponsor: Arrowhead Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

ARO-APOC3

ARO-APOC3 Injection

DRUG

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