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Antisense Oligonucleotide
Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia (SHASTA-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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial is testing a new treatment called ARO-APOC3 for people with very high levels of blood fats. The treatment involves two injections and works by reducing a protein that helps control these fats. The goal is to see if it is safe and effective.
Eligible Conditions
- Severe Hypertriglyceridemia
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
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: ARO-APOC3 50 mg, Day 1 and Week 12Experimental Treatment1 Intervention
2 doses of ARO-APOC3 by sc injection
Group II: ARO-APOC3 25 mg, Day 1 and Week 12Experimental Treatment1 Intervention
2 doses of ARO-APOC3 by sc injection
Group III: ARO-APOC3 10 mg, Day 1 and Week 12Experimental Treatment1 Intervention
2 doses of ARO-APOC3 by subcutaneous (sc) injection
Group IV: Placebo, Day 1 and Week 12Placebo Group1 Intervention
calculated volume to match active treatment by sc injection
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
41 Previous Clinical Trials
4,816 Total Patients Enrolled
5 Trials studying Hypertriglyceridemia
2,238 Patients Enrolled for Hypertriglyceridemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are open to receiving guidance on your diet from the study team based on the local standard of care.You agree to sign a written consent form and follow the study's rules.If you can get pregnant, you must have a negative pregnancy test, not be breastfeeding, and agree to use birth control.Based on your medical history, your triglyceride levels are very high (between 500 and 4000 mg/dL) during screening.Your triglyceride levels are very high and you have not eaten for a certain amount of time during screening.
Research Study Groups:
This trial has the following groups:- Group 1: ARO-APOC3 25 mg, Day 1 and Week 12
- Group 2: ARO-APOC3 10 mg, Day 1 and Week 12
- Group 3: ARO-APOC3 50 mg, Day 1 and Week 12
- Group 4: Placebo, Day 1 and Week 12
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.