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This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in subjects with elevated plasma Lipoprotein(a) [Lp(a)]. AMG 890 will be evaluated in approximately 80 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single Ascending Dose Cohorts |
|
| AMG 890 | Experimental | Single Ascending Dose Cohorts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 890 | Drug | Ascending Single Doses of AMG 890 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 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. | From first dose of trial until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Olpasiran | Blood samples were collected for measurement of serum concentrations of Olpasiran. | Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Tustin | California | 92780 | United States | ||
| Excel Medical Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35027752 | Background | Koren MJ, Moriarty PM, Baum SJ, Neutel J, Hernandez-Illas M, Weintraub HS, Florio M, Kassahun H, Melquist S, Varrieur T, Haldar SM, Sohn W, Wang H, Elliott-Davey M, Rock BM, Pei T, Homann O, Hellawell J, Watts GF. Preclinical development and phase 1 trial of a novel siRNA targeting lipoprotein(a). Nat Med. 2022 Jan;28(1):96-103. doi: 10.1038/s41591-021-01634-w. Epub 2022 Jan 13. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Participants were randomized in a 3:1 ratio to receive either Olpasiran or a volume-matched placebo via subcutaneous (SC) injection, across 9 single ascending dose cohorts.
Participants were enrolled at 8 research centers in the United States (US) and Australia between July 2018 and April 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants with screening plasma Lipoprotein(a) (Lp[a]) >=70 nmol/L and <199 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 1-5. Participants with screening plasma Lp(a) >=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 7, 2021 | Jan 13, 2026 |
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The subjects and the investigative site staff, except for the unblinded pharmacist, will be blinded to treatment assignment.
| Drug |
Calculated volume to match experimental drug. |
|
| Time to Reach Cmax (Tmax) of Olpasiran | Blood samples were collected for measurement of serum concentrations of Olpasiran. | Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose |
| Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint (AUC0-last) of Olpasiran | Blood samples were collected for measurement of serum concentrations of Olpasiran. | Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose |
| Change From Baseline in Plasma Lp(a) Levels | Change from baseline for plasma Lp(a) by cohort and at scheduled time points were presented. | Cohorts 1-2:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113;3-5:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113,155,183,225;6-7:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225;8-9:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225,253,281,309,337,365 |
| Percent Change From Baseline in Plasma Lp(a) Levels | Percent change from baseline for plasma Lp(a) by cohort and at scheduled time points during the treatment period were presented. | Cohorts 1-2:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113;3-5:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113,155,183,225;6-7:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225;8-9:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225,253,281,309,337,365 |
| Boca Raton |
| Florida |
| 33434 |
| United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| QPS Miami Research Associates | South Miami | Florida | 33143 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| New York University | New York | New York | 10016 | United States |
| Medpace Inc | Cincinnati | Ohio | 45227 | United States |
| Clinical Medical and Analytical eXellence CMAX | Adelaide | South Australia | 5000 | Australia |
| Linear Clinical Research Limited | Nedlands | Western Australia | 6009 | Australia |
| Cohort 1: Olpasiran 3 mg |
Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 3 mg as a single SC injection on Day 1. |
| FG002 | Cohort 2: Olpasiran 9 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. |
| FG003 | Cohort 3: Olpasiran 30 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1. |
| FG004 | Cohort 4 Olpasiran: 75 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. |
| FG005 | Cohort 5 Olpasiran: 225 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. |
| FG006 | Cohort 6: Olpasiran 9 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| FG007 | Cohort 7: Olpasiran 75 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| FG008 | Cohort 8: Olpasiran 225 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| FG009 | Cohort 9: Olpasiran 675 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| Participants Who Received Placebo in Cohorts 1-5 |
|
| Participants Who Received Placebo in Cohorts 6-9 |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
The safety analysis set consisted of all participants who received at least 1 dose of Olpasiran or placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 1-5. Participants with screening plasma Lp(a) >=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9. |
| BG001 | Cohort 1: Olpasiran 3 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 3 mg as a single SC injection on Day 1. |
| BG002 | Cohort 2: Olpasiran 9 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. |
| BG003 | Cohort 3: Olpasiran 30 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1. |
| BG004 | Cohort 4 Olpasiran: 75 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. |
| BG005 | Cohort 5 Olpasiran: 225 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. |
| BG006 | Cohort 6: Olpasiran 9 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| BG007 | Cohort 7: Olpasiran 75 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| BG008 | Cohort 8: Olpasiran 225 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| BG009 | Cohort 9: Olpasiran 675 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 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. | The safety analysis set consisted of all participants who received at least 1 dose of Olpasiran or placebo. | Posted | Count of Participants | Participants | From first dose of trial until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Concentration (Cmax) of Olpasiran | Blood samples were collected for measurement of serum concentrations of Olpasiran. | The pharmacokinetic (PK) analysis set consisted of all Olpasiran dosed participants for whom at least one PK parameter was reliably estimated. | Posted | Mean | Standard Deviation | ng/mL | Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach Cmax (Tmax) of Olpasiran | Blood samples were collected for measurement of serum concentrations of Olpasiran. | The PK analysis set consisted of all Olpasiran dosed participants for whom at least one PK parameter was reliably estimated. | Posted | Median | Full Range | hours | Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint (AUC0-last) of Olpasiran | Blood samples were collected for measurement of serum concentrations of Olpasiran. | The PK analysis set consisted of all Olpasiran dosed participants for whom at least one PK parameter was reliably estimated. | Posted | Mean | Standard Deviation | hour*ng/mL | Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Plasma Lp(a) Levels | Change from baseline for plasma Lp(a) by cohort and at scheduled time points were presented. | The pharmacodynamic (PD) analysis set consisted of all dosed participants for whom at least one PD parameter had a baseline value and at least 1 post-baseline measurement available. Participants with data available at each timepoint are presented. | Posted | Mean | Standard Deviation | nmol/L | Cohorts 1-2:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113;3-5:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113,155,183,225;6-7:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225;8-9:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225,253,281,309,337,365 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Plasma Lp(a) Levels | Percent change from baseline for plasma Lp(a) by cohort and at scheduled time points during the treatment period were presented. | The PD analysis set consisted of all dosed participants for whom at least one PD parameter had a baseline value and at least 1 post-baseline measurement available. Participants with data available at each timepoint are presented. | Posted | Mean | Standard Deviation | percent change | Cohorts 1-2:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113;3-5:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113,155,183,225;6-7:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225;8-9:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225,253,281,309,337,365 |
|
For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohorts 1-5: Placebo | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 1 -5. | 0 | 10 | 0 | 10 | 5 | 10 |
| EG001 | Cohorts 6-9: Placebo | Participants with screening plasma Lp(a) >=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9. | 0 | 10 | 1 | 10 | 7 | 10 |
| EG002 | Cohort 1: Olpasiran 3 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 3 mg as a single SC injection on Day 1. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | Cohort 2: Olpasiran 9 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG004 | Cohort 3: Olpasiran 30 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG005 | Cohort 4 Olpasiran: 75 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG006 | Cohort 5 Olpasiran: 225 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG007 | Cohort 6: Olpasiran 9 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. | 0 | 9 | 0 | 9 | 6 | 9 |
| EG008 | Cohort 7: Olpasiran 75 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. | 0 | 9 | 0 | 9 | 3 | 9 |
| EG009 | Cohort 8: Olpasiran 225 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG010 | Cohort 9: Olpasiran 675 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. | 0 | 6 | 0 | 6 | 4 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac telemetry abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Normal tension glaucoma | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Change of bowel habit | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oesophageal spasm | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oral mucosal blistering | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Medical device site dermatitis | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Animal scratch | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Ear injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Immunisation reaction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Vulvovaginal injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Smear cervix abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Pseudofolliculitis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Abdominoplasty | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
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| Mammoplasty | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
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| Tenolysis | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
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| Diastolic hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
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The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2023 | Jan 13, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Cohort 4 Olpasiran: 75 mg |
Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. |
| OG004 | Cohort 5 Olpasiran: 225 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. |
| OG005 | Cohort 6: Olpasiran 9 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| OG006 | Cohort 7: Olpasiran 75 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| OG007 | Cohort 8: Olpasiran 225 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| OG008 | Cohort 9: Olpasiran 675 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
|
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| Cohort 4 Olpasiran: 75 mg |
Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. |
| OG004 | Cohort 5 Olpasiran: 225 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. |
| OG005 | Cohort 6: Olpasiran 9 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| OG006 | Cohort 7: Olpasiran 75 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| OG007 | Cohort 8: Olpasiran 225 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| OG008 | Cohort 9: Olpasiran 675 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
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| OG003 | Cohort 4 Olpasiran: 75 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. |
| OG004 | Cohort 5 Olpasiran: 225 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. |
| OG005 | Cohort 6: Olpasiran 9 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| OG006 | Cohort 7: Olpasiran 75 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| OG007 | Cohort 8: Olpasiran 225 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| OG008 | Cohort 9: Olpasiran 675 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
|
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| OG003 | Cohort 3: Olpasiran 30 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1. |
| OG004 | Cohort 4 Olpasiran: 75 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. |
| OG005 | Cohort 5 Olpasiran: 225 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. |
| OG006 | Cohorts 6-9: Placebo | Participants with screening plasma Lp(a) >=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9. |
| OG007 | Cohort 6: Olpasiran 9 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| OG008 | Cohort 7: Olpasiran 75 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| OG009 | Cohort 8: Olpasiran 225 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| OG010 | Cohort 9: Olpasiran 675 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
|
|
| OG003 | Cohort 3: Olpasiran 30 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1. |
| OG004 | Cohort 4 Olpasiran: 75 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. |
| OG005 | Cohort 5 Olpasiran: 225 mg | Participants with screening plasma Lp(a) >=70 nmol/L and <199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. |
| OG006 | Cohorts 6-9: Placebo | Participants with screening plasma Lp(a) >=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9. |
| OG007 | Cohort 6: Olpasiran 9 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| OG008 | Cohort 7: Olpasiran 75 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| OG009 | Cohort 8: Olpasiran 225 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
| OG010 | Cohort 9: Olpasiran 675 mg | Participants with screening plasma Lp(a) >= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment. |
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