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 for the treatment of cardiometabolic disease. It is currently being studied in a Phase 1 clinical trial in participants with obesity. The drug is being evaluated for its safety, tolerability, and pharmacokinetics in this patient population.
AMG 513 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is currently conducting a Phase 1 clinical trial to evaluate the drug in participants with obesity and cardiometabolic disease.
AMG 513 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is a single and multiple ascending dose study designed to evaluate the drug's safety, tolerability, and pharmacokinetics in participants with obesity.
AMG 513 is being evaluated in a Phase 1 clinical trial with the identifier NCT06585462. This study is titled "Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity" and is currently recruiting participants in the United States. The trial is randomized, double-blind, and controlled, with an estimated enrollment of 80 participants.
AMG 513 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial is designed to assess the safety, tolerability, and pharmacokinetics of the drug in participants with obesity. Further clinical studies would be required before any regulatory approval could be considered.