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siRNA
ARO-ANG3 Injection for Homozygous Familial Hypercholesterolemia (Gateway 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
Weight of ≥ 40 kg and body mass index ≥ 18.5 and ≤ 40 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to week 36 (initial treatment period), up to month 24 (extension period) 36
Awards & highlights
Gateway Trial Summary
This trial is for people with HoFH who will receive 2 doses of ARO-ANG3 to see if it is safe and effective.
Who is the study for?
This trial is for individuals with a severe form of high cholesterol called homozygous familial hypercholesterolemia (HoFH). Participants must be on stable cholesterol-lowering therapy, not have heart disease symptoms or uncontrolled diabetes, and agree to use effective contraception. They should also follow a low-fat diet and have LDL-C levels over 100 mg/dL.Check my eligibility
What is being tested?
The study tests ARO-ANG3 injections in people with HoFH. It involves two initial doses followed by safety and effectiveness checks over 36 weeks. Those who finish can join a further 24-month extension for up to eight more doses.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to the ARO-ANG3 injection throughout the study period.
Gateway Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant or breastfeeding.
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I weigh at least 40 kg and my BMI is between 18.5 and 40.
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I have been diagnosed with HoFH either through genetic testing or based on my symptoms.
Gateway Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to week 36 (initial treatment period), up to month 24 (extension period) 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to week 36 (initial treatment period), up to month 24 (extension period) 36
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 Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) and LDL-C by Preparative Ultracentrifugation (LDL-C [PUC]) up to Week 24
Secondary outcome measures
Absolute Change from Baseline in Fasting ANGPTL3 Over Time
Absolute Change from Baseline in Fasting Calculated LDL-C Over Time
Absolute Change from Baseline in Fasting HDL-C Over Time
+19 moreGateway Trial Design
2Treatment groups
Experimental Treatment
Group I: ARO-ANG3 Dose 2Experimental Treatment1 Intervention
ARO-ANG3 Dose Level 2 SC
Group II: ARO-ANG3 Dose 1Experimental Treatment1 Intervention
ARO-ANG3 Dose Level 1 subcutaneous (SC)
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Who is running the clinical trial?
Arrowhead PharmaceuticalsLead Sponsor
39 Previous Clinical Trials
4,943 Total Patients Enrolled
1 Trials studying Hypercholesterolemia
93 Patients Enrolled for Hypercholesterolemia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your fasting triglyceride levels are higher than 300 mg/dL when tested before the study.I am on a stable dose of the highest safe cholesterol medication.I have a hormone-related condition affecting my cholesterol or fat levels.I am not pregnant or breastfeeding.I was diagnosed with diabetes in the last 3 months or my diabetes is not well-controlled (HbA1c > 9%).I haven't used any liver-targeting RNA or antisense drugs in the past year.I weigh at least 40 kg and my BMI is between 18.5 and 40.I haven't had a spreading cancer in the last 3 years, with some exceptions.I have severe heart muscle issues or chest pain due to poor blood flow.I am currently taking corticosteroids.I am currently using evinacumab, with some exceptions.I am scheduled for a heart or artery procedure.I have been on birth control for more than 2 menstrual cycles.I have been diagnosed with HoFH either through genetic testing or based on my symptoms.Your cholesterol levels are too high when you haven't eaten for a while.
Research Study Groups:
This trial has the following groups:- Group 1: ARO-ANG3 Dose 1
- Group 2: ARO-ANG3 Dose 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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