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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am not pregnant, not breastfeeding, and do not plan to become pregnant during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

Secondary outcome measures

Apolipoproteins

High Density Lipoproteins

Change from Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) Over Time Using Ultracentrifugation

+9 more

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arrowhead PharmaceuticalsLead Sponsor

39 Previous Clinical Trials

4,572 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this trial still ongoing?

"The records on clinicaltrials.gov reveal that this trial, initially posted July 7th 2022 and last updated November 17th 2022 is no longer recruiting participants; however, other 63 studies are presently welcoming volunteers for their trials."

Answered by AI

Is ARO-APOC3 proven to be safe for human consumption?

"Based on the available evidence, ARO-APOC3 is judged to have a safety level of 2. This signifies that Phase 2 clinical trials have been conducted which provide proof of its security but not yet any efficacy data."

Answered by AI

To what extent is this experiment being implemented across various locales?

"Currently, there are 16 different medical centres participating in this trial; located in New york, Dunwoody and San Antonio as well as 13 other locations. It is prudent to pick the closest site to minimize transport requirements if you choose to take part."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of ARO-APOC3 in Adults With Dyslipidemia

2022. "Study of ARO-APOC3 in Adults With Dyslipidemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05413135.