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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 week 48
Awards & highlights

SHASTA-2 Trial Summary

This trial is testing a new treatment for people with severe hypertriglyceridemia (high levels of fat in the blood). Participants will receive 2 injections of the new medication, and the effects will be monitored.

Eligible Conditions
  • Severe Hypertriglyceridemia

SHASTA-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 48 for reporting.

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 Triglycerides (TG) at Week 24
Secondary outcome measures
Change from Baseline in Plasma Concentration of ARO-APOC3 Over Time Through Week 48
Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) Possibly or Probably Related to Treatment
Percent Change from Baseline in ApoC-III Over Time Through Week 48
+10 more

SHASTA-2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ARO-APOC3Experimental Treatment1 Intervention
ARO-APOC3 Injection
Group II: PlaceboPlacebo Group1 Intervention
Sterile Normal Saline (0.9% NaCl)
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
39 Previous Clinical Trials
4,761 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, Placebo
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In which locales can this experiment be accessed?

"With 61 distinct sites, patients interested in the trial can explore various locations like Research Site in Port Orange, University of Minnesota in Houston, and Cardiology Associates Research, LLC in Boca Raton to name a few."

Answered by AI

What is the current status of ARO-APOC3 in terms of regulatory approval?

"Due to the Phase 2 nature of this trial, we assigned an intermediate safety score of 2 for ARO-APOC3 as there is some evidence supporting its security but none backing up its efficacy."

Answered by AI

How many participants have been recruited for this research project?

"Affirmative, the clinicaltrials.gov database shows that this experiment is actively seeking participants. It was initiated on May 31st 2021 and has since been revised on November 17th 2022. 300 human test subjects will be recruited from 61 distinct sites for this study."

Answered by AI

Is there still availability for enrolment in this trial?

"Affirmative, information on clinicaltrials.gov portrays that this research is presently searching for qualified participants.. This medical trial was first posted on May 31st 2021 and has been updated most recently on November 17th 2022. 300 individuals are needed to be recruited from 61 different sites."

Answered by AI

Who else is applying?

What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

My current statin medication has not been effective in lowering my Triglyceride levels, and I need to try some alternatives.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Baylor College of Medicine: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia
2021. "Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04720534.
~60 spots leftby Apr 2025
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