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Clinical Trials in Canada / NCT06347016
Active, not recruiting Phase 3

Study of Plozasiran in Adults With Severe Hypertriglyceridemia

NCT06347016 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2024-07-23
Last updated
2026-08-06

Condition(s) studied

Severe Hypertriglyceridemia

Investigational drug(s) / intervention(s)

Plozasiran Injection →Placebo

Plozasiran Injection: ARO-APOC3 Injection

Placebo: sterile normal saline (0.9% NaCl)

Study summary

This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After Month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥500 mg/dL (≥5.65 mmol/L) * Mean fasting TG level ≥500 mg/dL (≥5.65 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 * Fasting low density lipoprotein-cholesterol (LDL-C) ≤130 mg/dL (≤3.37 mmol/L) at screening * Screening HbA1C ≤9.0% * Must be on standard of care lipid-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator, including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or due to a previous adverse reaction associated with, attributed to, or caused by specific drug) Exclusion Criteria: * Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks * 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 (except inclisiran, which is permitted) * 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 * Body mass index \>45kg/m\^2 Note: Additional Inclusion/Exclusion criteria may apply per protocol

Primary outcome measure(s)

Trial sites (149)

FacilityCityRegionStatus
Research Site 1 Birmingham Alabama
Research Site 2 Mobile Alabama
Research Site 3 Beverly Hills California
Research Site 4 Canoga Park California
Research Site 5 Huntington Beach California
Research Site 6 Lincoln California
Research Site 7 Long Beach California
Research Site 8 Oxnard California
Research Site 9 Clearwater Florida
Research Site 10 North Miami Florida
Research Site 11 Sarasota Florida
Research Site 12 Lawrenceville Georgia
Research Site 13 Sugar Hill Georgia
Research Site 14 Elkhart Indiana
Research Site 15 Indianapolis Indiana
Research Site 16 South Bend Indiana
Research Site 17 Overland Park Kansas
Research Site 18 Topeka Kansas
Research Site 19 Metairie Louisiana
Research Site 20 Annapolis Maryland
Research Site 21 Jackson Mississippi
Research Site 22 Fremont Nebraska
Research Site 23 Norfolk Nebraska
Research Site 24 Morristown New Jersey
Research Site 26 New York New York
Research Site 27 Riverhead New York
Research Site 25 The Bronx New York
Research Site 28 Asheboro North Carolina
Research Site 29 Wilmington North Carolina
Research Site 30 Beavercreek Ohio
Research Site 31 Columbus Ohio
Research Site 32 Oklahoma City Oklahoma
Research Site 33 Horsham Pennsylvania
Research Site 34 Newport Pennsylvania
Research Site 35 Philadelphia Pennsylvania
Research Site 36 Philadelphia Pennsylvania
Research Site 37 Fort Mill South Carolina
Research Site 38 Greenville South Carolina
Research Site 39 Chattanooga Tennessee
Research Site 40 Fort Worth Texas

+ 109 more sites — see the full list on the official registry below.

More Arrowhead Pharmaceuticals trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06347016 on ClinicalTrials.gov ↗ ← All trials in Canada