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Antisense Oligonucleotide

Plozasiran for High Triglycerides (SHASTA-4 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 (≥5.65 mmol/L)
Be older than 18 years old
Must not have
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

Summary

"This trial will test a new injection called plozasiran in adults with very high levels of triglycerides. Participants will receive either plozasiran or a placebo every 3 months for a

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 and meet specific criteria for LDL cholesterol and HbA1C during screening. Participants should be on standard lipid-lowering medications unless they're 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, followed by an optional extension phase to further assess the drug's safety and effectiveness.
What are the potential side effects?
While the side effects of Plozasiran are not detailed here, common side effects from similar treatments may include injection site reactions, fatigue, nausea, liver enzyme changes, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe high blood fat levels with a past test showing over 500 mg/dL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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

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
39 Previous Clinical Trials
4,661 Total Patients Enrolled
5 Trials studying Hypertriglyceridemia
2,167 Patients Enrolled for Hypertriglyceridemia
~200 spots leftby Jul 2026
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