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Antisense Oligonucleotide

Plozasiran for High Triglycerides (MUIR-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 hypertriglyceridemia (HTG) with mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L) documented in medical history
Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial will test if plozasiran injection is safe and effective in adults with high triglyceride levels. Participants will receive either plozasiran or a placebo every 3 months for a

Who is the study for?
Adults with high triglycerides who have a stable blood sugar level (HbA1c ≤8.5%), can maintain a low-fat diet, and have LDL cholesterol levels within specific limits. Participants must have documented hypertriglyceridemia with certain fasting triglyceride levels, be on standard lipid-lowering medications unless intolerant.
What is being tested?
The trial is testing Plozasiran injections against a placebo in adults with hypertriglyceridemia to see if it's safe and effective. Participants will receive four doses over the course of a year, with each dose given every three months.
What are the potential side effects?
While the side effects for Plozasiran are not detailed here, common side effects for similar treatments include injection site reactions, fatigue, nausea, liver enzyme changes, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My medical records show I have high triglycerides between 150 and 499 mg/dL.
Select...
My fasting triglyceride levels are between 150 and 499 mg/dL, confirmed by two tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't used specific liver-targeted gene therapy recently.

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 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
41 Previous Clinical Trials
3,717 Total Patients Enrolled
~885 spots leftby Jul 2026
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