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

NCT04998201 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2026-04-14

Study results available
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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

DRUG

ARO-APOC3

ARO-APOC3 Injection

DRUG

Placebo

Sterile Normal Saline (0.9% NaCl)

Sponsors & Collaborators

  • Arrowhead Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-28
Primary Completion
2023-02-10
Completion
2023-08-14
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Hungary
  • New Zealand
  • Poland

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04998201 on ClinicalTrials.gov