Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Olpasiran
AMG 890 · 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...
Top 4 of 19 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 1 | PHASE3 | Ralinepag |
| Roivant Sciences Ltd. | ROIV | 3 | PHASE3 | Mosliciguat |
| Eli Lilly and Company | LLY | 1 | PHASE3 | Lepodisiran |
| Illumina, Inc. | ILMN | 1 | PHASE1 | 18F-mFBG for administration |
AMG 890 is an investigational RNA therapy being developed by Amgen Inc. for cardiovascular disease. It is designed to act on lipoprotein(a) and has been studied in a Phase 1 clinical trial in subjects with elevated plasma lipoprotein(a). It is not an approved medicine.
AMG 890 targets lipoprotein(a), often abbreviated Lp(a), a circulating lipoprotein associated with cardiovascular risk. It is an RNA therapy, meaning it works through an RNA-based mechanism directed at lipoprotein(a). The Phase 1 study enrolled subjects with elevated plasma lipoprotein(a).
AMG 890 is developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen is the sponsor of the clinical program studying the drug in cardiovascular disease.
AMG 890 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 study has been completed, and no active trials are currently listed for the program.
AMG 890 has been studied in one Phase 1 trial, NCT03626662, titled a safety, tolerability, pharmacokinetics and pharmacodynamics study of AMG 890 in subjects with elevated plasma lipoprotein(a). The trial was completed, enrolled 79 participants, was randomized, double-blind, and placebo-controlled, and ran in the United States and Australia.