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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 small molecule being developed for severe hypertriglyceridemia, hypertriglyceridemia, familial chylomicronemia syndrome, and familial chylomicronemia. It is in Phase 3 clinical development and has not been approved by the FDA. The drug has received Breakthrough Therapy designation from the FDA.
Plozasiran is a small interfering RNA (siRNA) therapeutic, classified under the -siran target class. It is designed to reduce the production of a protein involved in triglyceride metabolism, thereby lowering triglyceride levels in patients with hypertriglyceridemia and familial chylomicronemia syndrome.
Plozasiran is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ARWR. The company is conducting multiple Phase 3 clinical trials to evaluate the drug's safety and efficacy in patients with severe hypertriglyceridemia and familial chylomicronemia syndrome.
Plozasiran is in Phase 3 clinical development. It is not FDA approved and remains investigational. The drug has received Breakthrough Therapy designation from the FDA, which is granted to expedite the development and review of drugs for serious conditions where preliminary clinical evidence indicates substantial improvement over available therapies.
Plozasiran is being studied in four Phase 3 trials. NCT05089084 and NCT05902598 are completed studies in familial chylomicronemia syndrome. NCT06347133 is an active, not recruiting study in hypertriglyceridemia. NCT06822790 is a recruiting long-term safety and efficacy study in hypertriglyceridemia. These trials are randomized, double-blind, and placebo-controlled.
Yes, Plozasiran is also known as Plozasiran Injection. The drug is referred to by both names in clinical trial documentation and regulatory filings. It is also known by the research codes ARO-APOC3 and VSA001 in some studies, particularly those conducted in Chinese populations.