Phase 3Completed
Study of Plozasiran in Adults With Severe Hypertriglyceridemia (SHASTA-4)
Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozsiran in Adults With Severe Hypertriglyceridemia
- Sponsor
- Arrowhead Pharmaceuticals (Industry)
- Enrolment
- 311 enrolled
- Conditions
- Severe Hypertriglyceridemia
- Interventions
- Plozasiran Injection; Placebo
- Ages
- adults, older adults
- Registry
- NCT06347016, CTIS2023-509301-80-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Percent change in fasting serum TG levels from baseline to Month 12 compared to placebo
History
Last registry update
Study completion
Primary completion
Started
Registered