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Antisense Oligonucleotide
ARO-ANG3 for Dyslipidemia (ARCHES-2 Trial)
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
Women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to week 36 (double-blind treatment period), up to month 24 (open-label extension)
Awards & highlights
ARCHES-2 Trial Summary
This trial is testing a new drug, ARO-ANG3, to see if it is effective and safe in treating mixed dyslipidemia. Participants will receive injections of either the drug or a placebo, and then may continue receiving the drug in an extension of the trial.
Who is the study for?
This trial is for adults with mixed dyslipidemia who are not pregnant or breastfeeding, willing to follow diet counseling, and use effective contraception. They must have certain levels of blood fats after a stable diet and statin therapy. Exclusions include recent use of similar drugs, pancreatitis, uncontrolled thyroid issues, recent strokes or surgeries, uncontrolled hypertension, HIV/HBV/HCV infection.Check my eligibility
What is being tested?
The study tests ARO-ANG3's effectiveness and safety in managing mixed dyslipidemia compared to a placebo. Participants will receive two initial injections followed by an optional extension phase with up to eight additional doses.See study design
What are the potential side effects?
While the specific side effects are not listed here, common ones may include injection site reactions, potential liver enzyme changes due to drug mechanism action on lipid metabolism regulation.
ARCHES-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant or breastfeeding.
ARCHES-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to week 36 (double-blind treatment period), up to month 24 (open-label extension)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to week 36 (double-blind treatment period), up to month 24 (open-label extension)
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 TG at Week 24
Secondary outcome measures
Number of Participants With AEs and/or SAEs Over Time in the Double-Blind Treatment Period
Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and/or Serious TEAEs up to Week 24
+12 moreARCHES-2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ARO-ANG3Experimental Treatment1 Intervention
Two doses of ARO-ANG3 by subcutaneous (sc) injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Group II: PlaceboPlacebo Group2 Interventions
Calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARO-ANG3
2019
Completed Phase 1
~100
Find a Location
Who is running the clinical trial?
Arrowhead PharmaceuticalsLead Sponsor
39 Previous Clinical Trials
4,786 Total Patients Enrolled
3 Trials studying Dyslipidemias
864 Patients Enrolled for Dyslipidemias
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your medical history shows that your triglyceride levels are too high or too low.I have not had a bleeding stroke in the last 24 weeks.I have had cancer that needed treatment through the bloodstream in the last 2 years.I haven't had major surgery in the last 3 months and don't plan any during the study.I will not donate sperm during the study and for 6 months after the last dose.Your fasting triglyceride levels are between 150 and 499 mg/dL when measured at two different visits, which are at least 7 days but not more than 17 days apart.I have not had pancreatitis in the last 3 months.I am HIV positive or have Hepatitis B or C.I have been on birth control for at least 2 menstrual cycles.I have been diagnosed with nephrotic syndrome.My LDL-C is 70 mg/dL or higher, or my non-HDL-C is 100 mg/dL or higher, after 4 weeks on a stable diet and statin therapy.I haven't taken steroids in the last 4 weeks and don't plan to during the study.My thyroid condition is not under control.I plan to have weight loss surgery during the study.I am not pregnant or breastfeeding.I have a history of bleeding disorders.I haven't used any liver-targeting RNA or DNA drugs in the past year.I had a heart attack or related issue within the last 6 months.My high blood pressure is not under control.I am scheduled for a procedure to improve blood flow to my heart during the study.
Research Study Groups:
This trial has the following groups:- Group 1: ARO-ANG3
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
Is this research endeavor currently recruiting participants?
"According to clinicaltrials.gov, this study is not accepting new participants as of October 21st 2022. It was initially posted on June 28th 2021 and has since been updated multiple times. Fortunately, there are 63 other studies looking for patients right now that may be suitable alternatives."
Answered by AI
Are there a multitude of healthcare centers carrying out this investigation in Canada?
"This investigation is taking place at Research Site located in Québec, Quebec; WR-ClinSearch, LLC of Chattanooga, Tennessee; Office of Orlando Rivero MD based out of Hialeah, Florida as well as 35 other medical centres."
Answered by AI
Has the ARO-ANG3 drug been endorsed by the FDA?
"ARO-ANG3 was given a safety rating of 2, as the Phase 2 trial has provided evidence for its security but not yet verified efficacy."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Florida
How old are they?
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
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