Study of Plozasiran in Adults With Severe Hypertriglyceridemia

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Severe Hypertriglyceridemia

In brief

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.

Key facts

Study ID

NCT06347016

Run by

Arrowhead Pharmaceuticals

People needed

311

Starts

2024-07-23

Expected to finish

2026-09-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Research Site 2 — Mobile, Alabama, United States
• Research Site 3 — Beverly Hills, California, United States
• Research Site 4 — Canoga Park, California, United States
• Research Site 5 — Huntington Beach, California, United States
• Research Site 6 — Lincoln, California, United States
• Research Site 7 — Long Beach, California, United States
• Research Site 8 — Oxnard, California, United States
• Research Site 9 — Clearwater, Florida, United States
• Research Site 10 — North Miami, Florida, United States
• Research Site 11 — Sarasota, Florida, United States
• Research Site 12 — Lawrenceville, Georgia, United States
• Research Site 13 — Sugar Hill, Georgia, United States
• Research Site 14 — Elkhart, Indiana, United States
• Research Site 15 — Indianapolis, Indiana, United States
• Research Site 16 — South Bend, Indiana, United States
• Research Site 17 — Overland Park, Kansas, United States
• Research Site 18 — Topeka, Kansas, United States
• Research Site 19 — Metairie, Louisiana, United States
• Research Site 20 — Annapolis, Maryland, United States
• Research Site 21 — Jackson, Mississippi, United States
• Research Site 22 — Fremont, Nebraska, United States
• Research Site 23 — Norfolk, Nebraska, United States
• Research Site 24 — Morristown, New Jersey, United States
• Research Site 26 — New York, New York, United States
• Research Site 1 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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