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Antisense Oligonucleotide
ARO-APOC3 for Chylomicronemia Syndrome (PALISADE Trial)
Phase 3
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
Fasting TG ≥ 10 mmol/L (≥ 880 mg/dL) at screening refractory to standard lipid lowering therapy
Diagnosis of FCS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug through month 12 (randomized period) and through month 36 (open-label period)
Awards & highlights
PALISADE Trial Summary
This trial is testing a new medicine for people with a rare genetic disorder that causes high levels of certain fats in their blood.
Who is the study for?
Adults with familial chylomicronemia syndrome (FCS) who are willing to follow dietary advice and have very high fasting triglyceride levels. They must use effective contraception, not be pregnant or breastfeeding, and cannot have had major surgery or uncontrolled conditions like hypertension recently.Check my eligibility
What is being tested?
The trial is testing ARO-APOC3 against a placebo in adults with FCS. Participants will receive either the drug or placebo through subcutaneous injections over a period, followed by an open-label extension where all get ARO-APOC3.See study design
What are the potential side effects?
Potential side effects of ARO-APOC3 may include reactions at the injection site, changes in liver function tests, possible allergic responses, and other systemic symptoms that will be closely monitored throughout the study.
PALISADE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My fasting triglycerides are very high despite taking standard treatments.
Select...
I have been diagnosed with Familial Chylomicronemia Syndrome (FCS).
Select...
I am not pregnant or breastfeeding.
PALISADE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of study drug through month 12 (randomized period) and through month 36 (open-label period)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug through month 12 (randomized period) and through month 36 (open-label period)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Change from Baseline in Fasting Triglycerides (TG) at Month 10
Secondary outcome measures
Change from Baseline in Fasting TG Over Time
Number of Participants with Positively Adjudicated Events of Acute Pancreatitis
Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
+11 morePALISADE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ARO-APOC3Experimental Treatment1 Intervention
4 doses of ARO-APOC3 by subcutaneous (sc) injection (randomized period)
8 doses of ARO-APOC3 by sc injection (open-label period)
Group II: PlaceboPlacebo Group1 Intervention
calculated volume to match active treatment by sc injection (randomized period)
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
39 Previous Clinical Trials
4,886 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on HIV medication.I was diagnosed with diabetes recently or my HbA1c level is 9.0% or higher.I have not had pancreatitis in the last 3 months.I am using or willing to use effective birth control and will not donate sperm while on the study and for 24 weeks after.You have tested positive for hepatitis B virus (HBV) or hepatitis C virus (HCV).My fasting triglycerides are very high despite taking standard treatments.I have heart failure that affects my daily activities.I have been diagnosed with Familial Chylomicronemia Syndrome (FCS).I have been on birth control for at least 2 menstrual cycles.I haven't used liver-targeted gene therapy in the past year.I am not pregnant or breastfeeding.I have not had major surgery in the last 12 weeks.My blood pressure is not controlled by medication.I had a heart attack or related event in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: ARO-APOC3
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you tell me how many centers are conducting this research?
"11 research sites are participating in this study, which include Elkridge, Norfolk's New york University Langone Medical Center, and Washington University School of Medicine's Division of Endocrinology, Metabolism and Lipid Research in New York."
Answered by AI
Can new patients still join this clinical trial?
"That is correct. The most recent information on clinicaltrials.gov suggests that the study is still recruiting patients. This trial was first advertised on 1/11/2022 and has since been updated on 10/21/2022. There are 60 available spots for participants at 11 different locations."
Answered by AI
What is the government's opinion on ARO-APOC3?
"ARO-APOC3 falls into Phase 3 of clinical trials, meaning that there is already some data to support its efficacy and safety."
Answered by AI
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