Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

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

Conditions studied: Hypertriglyceridemia

In brief

This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). 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.

Key facts

Study ID

NCT06347133

Run by

Arrowhead Pharmaceuticals

People needed

1456

Starts

2024-05-21

Expected to finish

2026-09-01

Last updated by the study team

2026-06-26

Who can join

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

You may qualify if…

• Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening
• Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L)
• 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
• Fasting low density lipoprotein-cholesterol (LDL-C) ≤ 130 mg/dL (≤3.37 mmol/L) at screening
• Screening HbA1c ≤9.0%
• Willing to follow diet counseling and maintain a stable low-fat diet
• Must be on standard of care lipid and TG-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 a previous adverse reaction associated with, attributed to, or caused by specific drug) prior to collection of qualifying TG levels.

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
• Acute pancreatitis within 4 weeks prior to screening
• Body mass index >45 kg/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 — Garden Grove, California, United States
• Research Site 6 — Huntington Beach, California, United States
• Research Site 7 — Lake Forest, California, United States
• Research Site 8 — Lincoln, California, United States
• Research Site 9 — Long Beach, California, United States
• Research Site 10 — Montclair, California, United States
• Research Site 11 — Oxnard, California, United States
• Research Site 12 — Redding, California, United States
• Research Site 13 — Van Nuys, California, United States
• Research Site 14 — Colorado Springs, Colorado, United States
• Research Site 15 — Clearwater, Florida, United States
• Research Site 16 — Hialeah, Florida, United States
• Research Site 17 — Lake City, Florida, United States
• Research Site 18 — Miami Lakes, Florida, United States
• Research Site 19 — Mt. Dora, Florida, United States
• Research Site 20 — North Miami Beach, Florida, United States
• Research Site 21 — Orlando, Florida, United States
• Research Site 22 — Pensacola, Florida, United States
• Research Site 23 — Sarasota, Florida, United States
• Research Site 24 — Tamarac, Florida, United States
• Research Site 25 — Lawrenceville, Georgia, United States
• Research Site 1 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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