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Anti-sense Oligonucleotide

Plozasiran for High Triglycerides (SHASTA-3 Trial)

Phase 3
Recruiting
Research Sponsored by Arrowhead Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Established diagnosis of severe hypertriglyceridemia (SHTG) with prior documented evidence of fasting TG levels of ≥ 500 mg/dL (≥5.65mmol/L)
Be older than 18 years old
Must not have
Use of any other hepatocyte-targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer
Known diagnosis of familial chylomicronemia syndrome (FCS) (type 1 Hyperlipoproteinemia) by documentation of confirmed homozygote or double heterozygote for loss-of-function mutations in type 1-causing genes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial will test the safety and effectiveness of plozasiran injection in adults with severe high levels of triglycerides. Participants will receive either plozasiran or a placebo every 3 months

Who is the study for?
Adults with severe hypertriglyceridemia (very high triglycerides) can join this study. They must have a history of fasting triglyceride levels over 500 mg/dL, low LDL cholesterol at screening, stable blood sugar control (HbA1C ≤8.5%), and be willing to follow a low-fat diet while on standard lipid-lowering meds unless intolerant.
What is being tested?
The trial is testing Plozasiran injections against a placebo in adults with severe hypertriglyceridemia. Participants will receive four doses every three months and will be monitored for safety and effectiveness. After one year, they may continue in an extension study.
What are the potential side effects?
Potential side effects are not detailed here but could include reactions at the injection site, changes in liver function tests, fatigue or other symptoms related to lowering of triglycerides or immune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with very high blood fat levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't used specific liver-targeted gene therapies recently.
Select...
I have a confirmed genetic diagnosis of familial chylomicronemia syndrome.

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Plozasiran InjectionExperimental Treatment1 Intervention
4 doses of plozasiran (ARO-APOC3) by subcutaneous (sc) injection
Group II: PlaceboPlacebo Group1 Intervention
calculated volume to match active treatment by sc injection

Find a Location

Who is running the clinical trial?

Arrowhead PharmaceuticalsLead Sponsor
40 Previous Clinical Trials
4,562 Total Patients Enrolled
5 Trials studying Hypertriglyceridemia
2,062 Patients Enrolled for Hypertriglyceridemia
~270 spots leftby Jul 2026
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