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Clinical Trials in the UK / NCT06347133
Active, not recruiting Phase 3

Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

NCT06347133 · tracked via the Priya Life Science UK tracker
Sponsor
Arrowhead Pharmaceuticals
Phase
Phase 3
Started
2024-05-21
Last updated
2026-06-26

Condition(s) studied

Hypertriglyceridemia

Investigational drug(s) / intervention(s)

Plozasiran InjectionPlacebo

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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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. 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 * Acute pancreatitis within 4 weeks prior to screening * Body mass index \>45 kg/m\^2 Note: Additional Inclusion/Exclusion criteria may apply per protocol

Primary outcome measure(s)

Trial sites (235)

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 Garden Grove California
Research Site 6 Huntington Beach California
Research Site 7 Lake Forest California
Research Site 8 Lincoln California
Research Site 9 Long Beach California
Research Site 10 Montclair California
Research Site 11 Oxnard California
Research Site 12 Redding California
Research Site 13 Van Nuys California
Research Site 14 Colorado Springs Colorado
Research Site 15 Clearwater Florida
Research Site 16 Hialeah Florida
Research Site 17 Lake City Florida
Research Site 18 Miami Lakes Florida
Research Site 19 Mt. Dora Florida
Research Site 20 North Miami Beach Florida
Research Site 21 Orlando Florida
Research Site 22 Pensacola Florida
Research Site 23 Sarasota Florida
Research Site 24 Tamarac Florida
Research Site 25 Lawrenceville Georgia
Research Site 26 Macon Georgia
Research Site 27 Savannah Georgia
Research Site 28 Sugar Hill Georgia
Research Site 29 Park Ridge Illinois
Research Site 30 Elkhart Indiana
Research Site 31 Indianapolis Indiana
Research Site 32 South Bend Indiana
Research Site 33 Overland Park Kansas
Research Site 34 Topeka Kansas
Research Site 35 Louisville Kentucky
Research Site 36 Zachary Louisiana
Research Site 37 Annapolis Maryland
Research Site 38 Baltimore Maryland
Research Site 39 Flint Michigan
Research Site 40 Minneapolis Minnesota

+ 195 more sites — see the full list on the official registry below.

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 NCT06347133 on ClinicalTrials.gov ↗ ← All trials in the UK