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ACTIVE NOT RECRUITING
NCT05089084
PHASE3

Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)

Sponsor: Arrowhead Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 (plozasiran) in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all eligibility criteria will be randomized to receive 4 doses of plozasiran 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 plozasiran.

Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Familial Chylomicronemia Syndrome

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2021-12-14

Completion Date

2026-04

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DRUG

Plozasiran

ARO-APOC3 subcutaneous (SC) injection

DRUG

Placebo

sterile normal saline (0.9% NaCl) SC injection

Locations (58)

Clinical Site 1

Boca Raton, Florida, United States

Clinical Site 2

Suwanee, Georgia, United States

Clinical Site 3

Indianapolis, Indiana, United States

Clinical Site 4

Elkridge, Maryland, United States

Clinical Site 5

St Louis, Missouri, United States

Clinical Site 7

New York, New York, United States

Clinical Site 6

New York, New York, United States

Clinical Site 8

Austin, Texas, United States

Clinical Site 9

Norfolk, Virginia, United States

Clinical Site 10

Córdoba, Argentina

Clinical Site 11

Formosa, Argentina

Clinical Site 14

Camperdown, New South Wales, Australia

Clinical Site 15

St Leonards, New South Wales, Australia

Clinical Site 16

Melbourne, Victoria, Australia

Clinical Site 12

Melbourne, Australia

Clinical Site 13

Nedlands, Australia

Clinical Site 17

Graz, Austria

Clinical Site 18

Edegem, Belgium

Clinical Site 19

Ghent, Belgium

Clinical Site 20

Leuven, Belgium

Clinical Site 21

Liège, Belgium

Clinical Site 22

London, Ontario, Canada

Clinical Site 23

Toronto, Ontario, Canada

Clinical Site 24

Chicoutimi, Quebec, Canada

Clinical Site 25

Montreal, Quebec, Canada

Clinical Site 26

Québec, Quebec, Canada

Clinical Site 27

Zagreb, Croatia

Clinical Site 29

Marseille, Cedez 05, France

Clinical Site 28

Paris, France

Clinical Site 30

Jena, Germany

Clinical Site 31

Leipzig, Germany

Clinical Site 32

Galway, Ireland

Clinical Site 33

Jerusalem, Israel

Clinical Site 34

Chiba, Japan

Clinical Site 35

Ishikawa, Japan

Clinical Site 36

Osaka, Japan

Clinical Site 37

Tochigi, Japan

Clinical Site 38

Tokyo, Japan

Clinical Site 39

Tokyo, Japan

Clinical Site 41

Tlalpan, Mexico DF, Mexico

Clinical Site 42

Cuernavaca, Morelos, Mexico

Clinical Site 40

Mexico City, Mexico

Clinical Site 44

Auckland, New Zealand

Clinical Site 43

Auckland, New Zealand

Clinical Site 45

Christchurch, New Zealand

Clinical Site 46

Muscat, Oman

Clinical Site 47

Lodz, Poland

Clinical Site 48

Belgrade, Serbia

Clinical Site 49

Niš, Serbia

Clinical Site 50

Singapore, Singapore

Clinical Site 51

Gwangju, South Korea

Clinical Site 52

Seoul, South Korea

Clinical Site 53

A Coruña, Spain

Clinical Site 54

Granada, Spain

Clinical Site 55

Madrid, Spain

Clinical Site 56

Santiago de Compostela, Spain

Clinical Site 58

Melikgazi, Kayseri, Turkey (Türkiye)

Clinical Site 57

Izmir, Turkey (Türkiye)