Trials / Active Not Recruiting
Active Not RecruitingNCT06347133
Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Hypertriglyceridemia
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,456 (actual)
- Sponsor
- Arrowhead Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Plozasiran Injection | ARO-APOC3 Injection |
| DRUG | Placebo | sterile normal saline (0.9% NaCl) |
Timeline
- Start date
- 2024-05-21
- Primary completion
- 2026-05-01
- Completion
- 2026-09-01
- First posted
- 2024-04-04
- Last updated
- 2025-10-08
Locations
235 sites across 15 countries: United States, Argentina, Australia, Bulgaria, Canada, Czechia, France, Germany, Hungary, Italy, Poland, Slovakia, South Africa, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06347133. Inclusion in this directory is not an endorsement.