Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AMG 890
Olpasiran · 9 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.
An adverse event was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was defined as any event with onset after the administration of the first dose of investigational product and up to and including the end of treatment date, or end of trial for participants who discontinued the trial during the treatment period. Clinically significant changes in vital signs, electrocardiograms (ECGs), and safety laboratory analytes were included as TEAEs.
| 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. |
| AMG 890 | EXPERIMENTAL | Single Ascending Dose Cohorts |
| 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. |
| AMG 890 | DRUG | Ascending Single Doses of AMG 890 |
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 RNA therapy being developed for cardiovascular disease, including atherosclerotic cardiovascular disease and elevated serum lipoprotein(a). It is also being studied in basic science and in people with hepatic or renal impairment. It is not approved for any use and remains in clinical development.
Olpasiran targets LPA, the gene that encodes lipoprotein(a). It is an RNA interference (RNAi) inhibitor, a class of therapy that acts on RNA to reduce production of a specific protein. By targeting LPA, olpasiran is designed to lower lipoprotein(a) levels in the blood.
Olpasiran is being developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen is running the clinical development program, including the OCEAN(a) trials in cardiovascular disease and elevated lipoprotein(a).
Olpasiran is in Phase 3 clinical development. It is investigational and has not been approved by the FDA or any other regulator. The Phase 3 program includes the OCEAN(a)-Outcomes trial and the OCEAN(a)-PreEvent trial, both evaluating cardiovascular outcomes.
Olpasiran is being studied in several trials. NCT05581303, the OCEAN(a)-Outcomes trial, is active and not recruiting with 7,297 participants. NCT07136012, OCEAN(a)-PreEvent, is recruiting 11,000 participants. NCT07293260, a coronary CT angiography trial, is recruiting 406 participants, and NCT06411860, a QT/QTc study, is completed.
Olpasiran is the drug name, while OCEAN(a) refers to the clinical trial program evaluating it. OCEAN(a) stands for Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction. The program includes the OCEAN(a)-Outcomes trial, the OCEAN(a)-PreEvent trial, and a coronary computed tomography angiography trial.