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The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose (SAD) in Participants with Obesity (Part A) | Experimental | In Part A participants will enroll into SAD cohorts and will be randomized to receive AMG 513 or placebo subcutaneously (SC) or intravenously (IV). |
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| Multiple Ascending Dose (MAD) in Participants with Overweight or Obesity (Part B) | Experimental | In Part B participants will enroll into MAD cohorts and will be randomized to receive AMG 513 or placebo SC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 513 | Drug | AMG 513 will be administered by SC or IV injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Approximately 178 days (Part A) and 225 days (Part B) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Drug Concentration (Cmax) of AMG 513 | Day 1 up to Day 57 | |
| Time to Cmax (Tmax) of AMG 513 | Day 1 up to Day 57 | |
| Area Under the Concentration-time Curve (AUC) of AMG 513 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amgen Call Center | Contact | 866-572-6436 | medinfo@amgen.com |
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Recruiting | Anaheim | California | 92801 | United States | |
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| 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.
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| Placebo | Drug | Placebo will be administered by SC or IV injection. |
|
| AMG 513 | Drug | AMG 513 will be administered by SC injection. |
|
| Placebo | Drug | Placebo will be administered by SC injection. |
|
| Day 1 up to Day 57 |
| Orange County Research Center |
| Recruiting |
| Lake Forest |
| California |
| 92630 |
| United States |
| Fomat Medical Research | Recruiting | Oxnard | California | 93030 | United States |
| Translational Clinical Research LLC | Recruiting | Aventura | Florida | 33180 | United States |
| Clinical Neuroscience Solutions - Jacksonville | Recruiting | Jacksonville | Florida | 32256 | United States |
| New Horizon Research Center | Recruiting | Miami | Florida | 33165 | United States |
| Clinical Pharmacology of Miami, LLC | Recruiting | Miami | Florida | 33172 | United States |
| Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group | Recruiting | Union City | Georgia | 30291 | United States |
| Lillestol Research LLC | Recruiting | Fargo | North Dakota | 58104 | United States |
| Pinnacle Clinical Research | Recruiting | Austin | Texas | 78757 | United States |