Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 513 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 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). |
| 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. |
| Name | Type | Description |
|---|---|---|
| AMG 513 | DRUG | AMG 513 will be administered by SC or IV injection. |
| Placebo | DRUG | Placebo will be administered by SC or IV injection. |
Inclusion Criteria: * Participants in the study will be males and females 18 to 65 years of age at the time of signing the informed consent with a body mass index (BMI) of 30.0 kg/m\^2 to 40.0 kg/m\^2 for Part A and BMI of 27.0 kg/m\^2 to 40.0 kg/m\^2 for Part B. * Females enrolled must be of non-c...
AMG 513 is an investigational small molecule being developed by Amgen Inc. for cardiometabolic disease. It has been studied in a Phase 1 clinical trial in participants with obesity. AMG 513 is not approved and remains in clinical development.
AMG 513 is being developed for cardiometabolic disease, with its Phase 1 study conducted in participants with obesity. It is an investigational therapy and has not been approved for any indication. Its use remains limited to clinical research at this stage.
AMG 513 is developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen is the sponsor of the clinical program evaluating the small molecule in cardiometabolic disease.
AMG 513 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
AMG 513 has been evaluated in the Phase 1 trial NCT06585462, titled Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity. The trial enrolled 82 participants in the United States, was randomized, double-blind, and controlled, and has been completed.