Shasta-3
Posted Date: Feb 20, 2025
- Investigator: Dylan Steen
- Specialties:
- Type of Study: Drug
This study investigates plozasiran (ARO-APOC3) as a potential treatment for severe hypertriglyceridemia (SHTG) in adults. Severe hypertriglyceridemia is characterized by extremely high levels of triglycerides in the blood, which can lead to serious health issues such as pancreatitis and cardiovascular diseases. The study is a Phase 3, double-blind, placebo-controlled trial. Participants will be randomly assigned to receive either plozasiran or a placebo. The treatment involves four doses administered once every three months over a 12-month period. After the initial 12 months, eligible participants may continue in an optional open-label extension. The primary outcome is the percentage change in fasting serum triglyceride levels from baseline to month 12. Secondary outcomes include changes in triglyceride levels at months 10 and 12, the proportion of participants reaching specific triglyceride thresholds, occurrence of abdominal clinical events, adverse events, rates of new-onset diabetes, and changes in HbA1c, blood glucose, and insulin resistance.
Criteria:
Adults With Severe Hypertrigyceridemia [Fasting Tg Levels Of =500 Mg/Dl (=5.65 Mmol/L)]
Keywords:
Plozasiran Drug In Patients With Severe Hypertriglyceridemia
For More Information:
Dhruvi Joshi
513-558-3711
joshidv@ucmail.uc.edu