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Antisense Oligonucleotide

ARO-APOC3 for 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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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
40 Previous Clinical Trials
4,738 Total Patients Enrolled
5 Trials studying Hypertriglyceridemia
2,238 Patients Enrolled for Hypertriglyceridemia

Media Library

ARO-APOC3 (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT04720534 — Phase 2
Hypertriglyceridemia Research Study Groups: ARO-APOC3 25 mg, Day 1 and Week 12, ARO-APOC3 10 mg, Day 1 and Week 12, ARO-APOC3 50 mg, Day 1 and Week 12, Placebo, Day 1 and Week 12
Hypertriglyceridemia Clinical Trial 2023: ARO-APOC3 Highlights & Side Effects. Trial Name: NCT04720534 — Phase 2
ARO-APOC3 (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04720534 — Phase 2
~52 spots leftby Nov 2025
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