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Antisense Oligonucleotide

ARO-APOC3 for Dyslipidemia

Phase 2
Waitlist Available
Research Sponsored by Arrowhead Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults who are nonpregnant, nonlactating and do not plan to become pregnant during the study
Be older than 18 years old
Must not have
Subject was permanently discontinued from ARO-APOC3 in the parent study due to elevated glycated hemoglobin (HbA1c), aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is for people who have already completed a study on a similar topic and who meet certain criteria. All participants will take the same dosage of medicine.

Who is the study for?
This trial is for adults with dyslipidemia who completed a previous 12-month study (AROAPOC3-2001 or AROAPOC3-2002) and are not pregnant, nor planning to become pregnant. Participants must be willing to limit alcohol and have no new conditions that could affect their participation or increase risk.
What is being tested?
Participants will receive an open-label drug called ARO-APOC3. Initially, they'll get the dose from the prior studies until a final dose is chosen. Then everyone will switch to this selected dosing regimen to continue evaluating its effects on dyslipidemia.
What are the potential side effects?
Specific side effects of ARO-APOC3 aren't listed here, but participants were excluded if they previously had significant increases in blood sugar (HbA1c) or liver enzymes (AST/ALT) due to the drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant, not breastfeeding, and do not plan to become pregnant during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was taken off ARO-APOC3 in a previous study due to high blood sugar or liver enzyme levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ARO-APOC3Experimental Treatment1 Intervention
1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 or 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARO-APOC3
2019
Completed Phase 2
~700

Find a Location

Who is running the clinical trial?

Arrowhead PharmaceuticalsLead Sponsor
40 Previous Clinical Trials
4,549 Total Patients Enrolled

Media Library

ARO-APOC3 (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05413135 — Phase 2
Dyslipidemia Clinical Trial 2023: ARO-APOC3 Highlights & Side Effects. Trial Name: NCT05413135 — Phase 2
Dyslipidemia Research Study Groups: ARO-APOC3
ARO-APOC3 (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05413135 — Phase 2
~110 spots leftby Oct 2025