Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 786 · 1 trial · 1 indication
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...
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AMG 786 is an investigational small molecule being developed for the treatment of obesity. It is a metabolic therapeutic that has been studied in a Phase 1 clinical trial. The drug is not yet approved and remains in clinical development.
AMG 786 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 1 clinical development for obesity.
AMG 786 is in Phase 1 clinical development. It has completed a Phase 1 trial, and it is not yet approved by regulatory authorities. The drug remains investigational and is being studied for the treatment of obesity.
AMG 786 has been studied in one completed Phase 1 clinical trial, identified as NCT05406115. This trial was a single and multiple ascending dose study that evaluated AMG 786 in healthy participants and participants with obesity. The trial enrolled 65 participants in the United States.
AMG 786 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial for obesity. The drug is still in clinical development and has not been approved for any use.