Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARO-APOC3 · 4 trials · 5 indications
Least square (LS) mean and standard error (SE) were calculated using mixed model repeated measures (MMRM) which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
| Arm | Type | Description |
|---|---|---|
| ARO-APOC3 | EXPERIMENTAL | 1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 months |
| ARO-APOC3 10 mg Q12W | EXPERIMENTAL | ARO-APOC3 10 milligrams (mg) subcutaneous (SC) injection on Day 1 and Week 12 (Q12W) for a total of 2 injections |
| ARO-APOC3 25 mg Q12W | EXPERIMENTAL | ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections |
| ARO-APOC3 50 mg Q12W | EXPERIMENTAL | ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections |
| ARO-APOC3 50 mg Q24W | EXPERIMENTAL | ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections |
| Placebo | PLACEBO_COMPARATOR | Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections |
| Placebo, Day 1 and Week 12 | EXPERIMENTAL | Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections. |
| ARO-APOC3 10 mg | EXPERIMENTAL | Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections. |
| ARO-APOC3 25 mg | EXPERIMENTAL | Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections. |
| ARO-APOC3 50 mg | EXPERIMENTAL | Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections. |
| Name | Type | Description |
|---|---|---|
| ARO-APOC3 | DRUG | ARO-APOC3 Injection |
| Placebo | DRUG | Sterile Normal Saline (0.9% NaCl) |
| sterile normal saline (0.9% NaCl) | DRUG | calculated volume to match active treatment |
Inclusion Criteria: * Adults who are nonpregnant, nonlactating and do not plan to become pregnant during the study * Able and willing to provide written informed consent * Completed the 48-week study treatment period in the parent study Exclusion Criteria: * Subject was permanently discontinued f...
ARO-APOC3 is an investigational drug being studied for the treatment of hypertriglyceridemia, mixed dyslipidemia, severe hypertriglyceridemia, and dyslipidemias. It is being developed by Arrowhead Pharmaceuticals for cardiovascular conditions. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
ARO-APOC3 targets apolipoprotein C3, a protein involved in triglyceride metabolism. By reducing the production of this protein, the drug aims to lower triglyceride levels in the blood. This mechanism is being investigated for its potential to treat conditions characterized by elevated triglycerides, such as hypertriglyceridemia and mixed dyslipidemia.
ARO-APOC3 is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ARWR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with various lipid disorders, including severe hypertriglyceridemia and mixed dyslipidemia.
ARO-APOC3 is in Phase 2 clinical development. Multiple Phase 2 trials have been completed, including studies in adults with severe hypertriglyceridemia, mixed dyslipidemia, and dyslipidemias. The drug is investigational and has not received FDA approval. Earlier Phase 1 studies have also been completed in healthy volunteers and patients with hypertriglyceridemia.
ARO-APOC3 has been studied in several completed clinical trials. NCT04720534 evaluated the drug in adults with severe hypertriglyceridemia, NCT04998201 studied it in mixed dyslipidemia, and NCT05413135 examined its effects in dyslipidemias. An earlier Phase 1 trial, NCT03783377, included healthy volunteers and patients with hypertriglyceridemia or familial chylomicronemia syndrome.
Yes, ARO-APOC3 is also known as plozasiran. In clinical trials, the drug has been referred to by both names. For example, NCT04998201 is titled 'Study of Plozasiran (ARO-APOC3) in Adults With Mixed Dyslipidemia.' Researchers and clinicians may use either name when referring to this investigational therapy.