Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Olpasiran · 8 trials · 6 indications
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
The serum pharmacokinetic (PK) parameters of olpasiran were calculated using standard noncompartmental methods.
| Arm | Type | Description |
|---|---|---|
| Olpasiran | EXPERIMENTAL | Participants will receive olpasiran subcutaneously (SC) once every 12 weeks (Q12W). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo SC Q12W. |
| Arm 1 Olpasiran Dose 1 | ACTIVE_COMPARATOR | - |
| Arm 2 Olpasiran Dose 2 | ACTIVE_COMPARATOR | - |
| Arm 3 Olpasiran Dose 3 | ACTIVE_COMPARATOR | - |
| Arm 4 Olpasiran Dose 4 | ACTIVE_COMPARATOR | - |
| Arm 5 Placebo Dose 5 | PLACEBO_COMPARATOR | - |
| Treatment A | PLACEBO_COMPARATOR | All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin |
| Treatment B | EXPERIMENTAL | All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin |
| Treatment C | EXPERIMENTAL | All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin |
| Treatment D | ACTIVE_COMPARATOR | All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin |
| Single Dose Olpasiran Hepatic Impairment | EXPERIMENTAL | Participants will be enrolled in 1 of 3 hepatic impairment groups based on their hepatic impairment status, as determined by Child-Pugh classification. All participants will receive a single dose of olpasiran on Day 1. |
| Single Dose Olpasiran Normal Hepatic Function | EXPERIMENTAL | Participants with normal hepatic function will be enrolled and will receive a single dose of olpasiran on Day 1. |
| Single Dose Olpasiran Renal Impairment | EXPERIMENTAL | Participants will be enrolled in 1 of 5 renal function groups based on their renal impairment status, as determined by estimated glomerular filtration rate (eGFR). All participants will receive a single dose of olpasiran on Day 1. |
| Single Dose Olpasiran Normal Renal Function | EXPERIMENTAL | Participants with normal renal function will be enrolled and will receive a single dose of olpasiran on Day 1. |
| Olpasiran Dose A | EXPERIMENTAL | Participants will be administered Olpasiran dose A as a subcutaneous injection. |
| Olpasiran Dose B | EXPERIMENTAL | Participants will be administered Olpasiran dose B as a subcutaneous injection. |
| Name | Type | Description |
|---|---|---|
| Olpasiran | DRUG | Olpasiran will be administered SC. |
| Placebo | DRUG | Placebo will be administered SC. |
| Moxifloxacin | DRUG | Participants will receive a single dose of moxifloxacin as an oral tablet by mouth. |
Inclusion Criteria: * Age 35 to ≤ 80 years. * Lp(a) ≥ 200 nmol/L during screening. * Angiographic evidence of coronary artery disease in at least one major epicardial vessel on screening CCTA. * History of myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or coronary r...
Olpasiran is an investigational small molecule siRNA being developed for cardiovascular disease, specifically for conditions related to elevated serum lipoprotein(a) and atherosclerotic cardiovascular disease. It is also being studied in patients with hepatic or renal impairment to understand how the body processes the drug.
Olpasiran is a small interfering RNA (siRNA) that targets the production of lipoprotein(a), a risk factor for cardiovascular disease. By reducing elevated serum lipoprotein(a) levels, it aims to address atherosclerotic cardiovascular disease. The drug is designed to lower this specific lipid particle.
Olpasiran is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. Amgen is conducting clinical trials to evaluate the drug's safety and efficacy in patients with elevated lipoprotein(a) and cardiovascular conditions.
Olpasiran is currently in Phase 3 clinical development. The most advanced trial, OCEAN(a) Outcomes Trial (NCT05581303), is active but not recruiting and is evaluating the drug's effect on cardiovascular events in patients with atherosclerotic cardiovascular disease.
Olpasiran has been studied in four clinical trials. The Phase 3 OCEAN(a) Outcomes Trial (NCT05581303) is active with 7,297 participants. Completed Phase 1 trials include NCT04987320 in Chinese participants with elevated lipoprotein(a), NCT05481411 in hepatic impairment, and NCT06411860 assessing QT/QTc intervals in healthy participants.
Olpasiran is not FDA approved. It is an investigational drug currently in Phase 3 clinical trials. The drug has not yet completed the regulatory approval process, and its safety and efficacy are still being evaluated in clinical studies.