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Also known as Plozasiran Injection
Plozasiran · 7 trials · 4 indications
Blood samples for lipid parameters were collected at the specified time points. Fasting serum TG at Month 10 was defined as geometric mean of 2 measurements taken during Month 10, or the other non-missing measurement if any one of the two measurements was missing during Month 10. Analysis was performed on the basis of the handling strategy for intercurrent events, missing fasting serum was imputed mainly based on the Pattern Mixture Models (PMM). Descriptive statistics were calculated based on non-imputed data.
| Arm | Type | Description |
|---|---|---|
| Plozasiran Injection | EXPERIMENTAL | Plozasiran by SC injection every 3 months (Q3M) through completion of the randomized period Plozasiran by SC injection Q3M through completion of the OLE period |
| Placebo | EXPERIMENTAL | calculated volume to match active treatment by SC injection (randomized period) |
| Plozasiran 25 mg | EXPERIMENTAL | Plozasiran 25 mg administered every 3 months for 12 months (randomized period), followed by an open-label period of 12 months |
| Plozasiran 50 mg | EXPERIMENTAL | Plozasiran 50 mg administered every 3 months for 12 months (randomized period), followed by an open-label period of 12 months |
| ARO-APOC3 (Plozasiran) 25 mg | EXPERIMENTAL | Randomized Period: plozasiran 25 mg Q3M for a total of 4 doses. Open-label Period (Parts A and B): plozasiran 25 mg Q3M for a total of 8 doses. |
| Placebo for ARO-APOC3 (Plozasiran) 25 mg | PLACEBO_COMPARATOR | Randomized Period: volume-matched placebo every 3 months (Q3M) for a total of 4 doses. Open-label Period (Parts A and B): plozasiran 25 mg Q3M for a total of 8 doses. |
| ARO-APOC3 (Plozasiran) 50 mg | EXPERIMENTAL | Randomized Period: plozasiran 25 mg Q3M for a total of 4 doses. Open-label Period: plozasiran 50 mg (Part A), then 25 mg (Part B) Q3M for a total of 8 doses. |
| Placebo for ARO-APOC3 (Plozasiran) 50 mg | PLACEBO_COMPARATOR | Randomized Period: volume-matched placebo every 3 months (Q3M) for a total of 4 doses. Open-label Period: plozasiran 50 mg (Part A), then 25 mg (Part B) Q3M for a total of 8 doses. |
| Name | Type | Description |
|---|---|---|
| Plozasiran | DRUG | ARO-APOC3 injection |
| Placebo | DRUG | sterile normal saline (0.9% NaCl) |
| Plozasiran Injection | DRUG | ARO-APOC3 injection |
| Placebon | DRUG | Subcutaneous injection |
Inclusion Criteria: * Males, or nonpregnant (who do not plan to become pregnant) nonlactating females * Established diagnosis of SHTG and prior documented evidence of fasting TG levels of ≥ 880 mg/dL (≥ 10 mmol/L) * Documented evidence of at least 1 prior AP event not attributed to other etiologies...
Plozasiran is an investigational RNA therapy being developed for hypertriglyceridemia and familial chylomicronemia syndrome. It is designed to reduce triglyceride levels in adults with these lipid disorders. Arrowhead Pharmaceuticals, Inc. (ticker ARWR) is developing the drug, which is currently in Phase 3 clinical development.
Plozasiran targets APOC3, apolipoprotein C-III. It belongs to the -siran small interfering RNA (siRNA) class of RNA therapies. By targeting APOC3, the drug is designed to reduce production of this protein, which regulates triglyceride metabolism. This mechanism underlies its development for hypertriglyceridemia and familial chylomicronemia syndrome.
Plozasiran is being developed by Arrowhead Pharmaceuticals, Inc., which trades under the ticker ARWR. Arrowhead is the sponsor of the Phase 3 clinical trials evaluating the drug in hypertriglyceridemia and related lipid disorders.
Plozasiran is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The FDA has granted it Breakthrough Therapy and Priority Review designations. Three Phase 3 trials are active, and one earlier trial has been completed.
Plozasiran is being studied in Phase 3 trials including NCT06880770 in severe hypertriglyceridemia at risk of acute pancreatitis, NCT06822790 evaluating long-term safety and efficacy in hypertriglyceridemia, NCT06347133 in hypertriglyceridemia, and NCT06347016 in severe hypertriglyceridemia. These trials are randomized, double-blind, and placebo-controlled, with enrollment totaling 2,325 participants.
Yes. Plozasiran Injection is another name for Plozasiran. Both refer to the same investigational RNA therapy developed by Arrowhead Pharmaceuticals, Inc. (ARWR) for hypertriglyceridemia and familial chylomicronemia syndrome. The drug is currently in Phase 3 clinical development.