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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514336-24-00

Acronym

AROAPOC3-3001

Enrollment

Registered

2024-09-26

Start date

2022-03-24

Completion date

Unknown

Last updated

2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Chylomicronemia Syndrome (FCS)

Brief summary

Percent change from baseline at Month 10 in fasting TG

Detailed description

Percent change from baseline at Months 10 and 12 (averaged) in fasting TG, Percent change from baseline at Month 10 in fasting APOC3, Percent change from baseline at Month 12 in fasting APOC3

Interventions

DRUGARO-APOC3

DRUG0.9% Normal Saline for injection

DRUGARO-APOC3 PFS

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline at Month 10 in fasting TG	—

Secondary

Measure	Time frame
Percent change from baseline at Months 10 and 12 (averaged) in fasting TG, Percent change from baseline at Month 10 in fasting APOC3, Percent change from baseline at Month 12 in fasting APOC3	—

Countries

Austria, Belgium, Croatia, France, Ireland, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026