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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05406115 | Single and Multiple Ascending Dose Study to Evaluate AMG 786 in Healthy Participants and Participants With Obesity | PHASE1 | COMPLETED | 65 | — | — | Jul 26, 2022 | Aug 21, 2023 | Oct 27, 2025 | 3 | United States |
Any clinically significant changes in vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory tests will be recorded as TEAEs.
| Arm | Type | Description |
|---|---|---|
| Part A: Single Ascending Dose Cohorts | EXPERIMENTAL | Participants in 4 cohorts will receive either AMG 786 or placebo in Single Ascending Doses. |
| Part A: Food Effect Cohort | EXPERIMENTAL | Participants in the food effect cohort (FEC) will receive 1 of 2 AMG 786 in 1 of two sequences. Participants in Sequence 1 will receive a dose of AMG 786 on day 1 under fed conditions followed by a 10-day washout period and another dose of AMG 786 on day 11 under fasted conditions. Participants in Sequence 2 in the FEC cohort will receive the first dose on day 1 under fasted conditions and the second dose on day 11 under fed conditions. |
| Part B: Multiple Ascending Dose Cohorts | EXPERIMENTAL | Participants in 4 cohorts will receive either AMG 786 or placebo in Multiple Ascending Doses. |
| Name | Type | Description |
|---|---|---|
| AMG 786 | DRUG | Oral tablet |
| Placebo | OTHER | Oral tablet |
Inclusion Criteria: * Participant has provided informed consent/assent prior to initiation of any study-specific activities/procedures * Age 18 to 65 years at the time of signing the informed consent * Female participants must be of non-childbearing potential (as described below) * Postmenopausa...