NCT04998201

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

A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Mixed Dyslipidemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: Arrowhead Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mixed Dyslipidemia

Interventions

Type	Name	Description
DRUG	ARO-APOC3	ARO-APOC3 Injection
DRUG	Placebo	Sterile Normal Saline (0.9% NaCl)

Timeline

• Start date: 2021-09-28
• Primary completion: 2023-02-10
• Completion: 2023-08-14
• First posted: 2021-08-10
• Last updated: 2026-04-14
• Results posted: 2026-02-24

Locations

30 sites across 6 countries: United States, Australia, Canada, Hungary, New Zealand, Poland

Regulatory

• FDA-regulated drug study