CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 75 enrolled / 75 target
Drug / intervention
Plozasiran +1 moredrug
Likely dose
25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05089084
NCT05089084Phase 3CompletedMonitor (1.4/mo)Completion was 26mo ago
CompareCT.gov

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

Arrowhead Pharmaceuticals·interventional·Posted Oct 22, 2021·Updated Jun 5, 2026

In Brief

A Phase 3 clinical trial evaluating Plozasiran and Placebo for Familial Chylomicronemia. Completed, enrolled 75 participants across 58 sites in 21 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFamilial Chylomicronemia
CountriesArgentina, Australia, Austria, Belgium, Canada, Croatia, France, Germany, Ireland, Israel, Japan, Mexico, New Zealand, Oman, Poland, Serbia, Singapore, South Korea, Spain, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedOct 22, 2021
Enrollment StartDec 14, 2021
Primary CompletionApr 29, 2024
Study CompletionApr 21, 2026
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.7 years ago

Arms & Interventions

ARO-APOC3 (Plozasiran) 25 mgexperimental

Randomized Period: plozasiran 25 mg Q3M for a total of 4 doses. Open-label Period (Parts A and B): plozasiran 25 mg Q3M for a total of 8 doses.

Drug: Plozasiran
Placebo for ARO-APOC3 (Plozasiran) 25 mgplacebo_comparator

Randomized Period: volume-matched placebo every 3 months (Q3M) for a total of 4 doses. Open-label Period (Parts A and B): plozasiran 25 mg Q3M for a total of 8 doses.

Drug: PlozasiranDrug: Placebo
ARO-APOC3 (Plozasiran) 50 mgexperimental

Randomized Period: plozasiran 25 mg Q3M for a total of 4 doses. Open-label Period: plozasiran 50 mg (Part A), then 25 mg (Part B) Q3M for a total of 8 doses.

Drug: Plozasiran
Placebo for ARO-APOC3 (Plozasiran) 50 mgplacebo_comparator

Randomized Period: volume-matched placebo every 3 months (Q3M) for a total of 4 doses. Open-label Period: plozasiran 50 mg (Part A), then 25 mg (Part B) Q3M for a total of 8 doses.

Drug: PlozasiranDrug: Placebo

Interventions

Plozasirandrug

ARO-APOC3 subcutaneous (SC) injection

Placebodrug

sterile normal saline (0.9% NaCl) SC injection