Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06585462 | Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity | PHASE1 | RECRUITING | 80 | — | — | Sep 9, 2024 | Oct 1, 2026 | Jun 4, 2026 | 7 | United States |
| 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...