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ARO-ANG3 Injection for Homozygous Familial Hypercholesterolemia (Gateway Trial)
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.
Gateway Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowGateway Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Gateway Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: ARO-ANG3 Dose 1
- Group 2: ARO-ANG3 Dose 2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What are the official regulatory rulings on ARO-ANG 3 Injection?
"ARO-ANG 3 Injection's safety is relatively unknown as this drug is still in Phase 2 trials. While there are preliminary data supporting that it is safe, none of the current information suggests that it is an effective medication."
Are patients being actively sought for this experiment as of now?
"That is correct. The listing on clinicaltrials.gov does show that the trial is still opening spots for patients. According to the information provided, the 5 sites began recruiting on 4/22/2022 and the most recent update was 9/26/2022. A total of 16 people are needed for this study."
Are there different hospitals conducting this research in North America?
"To make things more convenient for potential participants, this study is enrolling at 5 sites which are situated in close proximity to Cincinnati, Mount Sinai and Québec City. There are also other centres in 5 additional locations."
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