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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 belowSelect...
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:Select...
I was taken off ARO-APOC3 in a previous study due to high blood sugar or liver enzyme levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, not breastfeeding, and do not plan to become pregnant during the study.I was taken off ARO-APOC3 in a previous study due to high blood sugar or liver enzyme levels.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: ARO-APOC3
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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