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AMG 786

Phase 1

Obesity | Small molecule | Metabolic |Amgen Inc.|Last Updated: Oct 27, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

AMG 786 · 1 trial · 1 indication

Phase 1 1
NCT05406115Single and Multiple Ascending Dose Study to Evaluate AMG 786 in Healthy Participants and Participants With ObesityObesity
COMPLETED65 Analytics
PHASE1COMPLETED
Single and Multiple Ascending Dose Study to Evaluate AMG 786 in Healthy Participants and Participants With Obesity
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
Day 1 through end of study (approximately 40 days)

Any clinically significant changes in vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory tests will be recorded as TEAEs.

Secondary Endpoints

Maximum Observed Concentration (Cmax) of AMG 786
Day 1 through end of study (approximately 40 days)
Time of Maximum Observed Concentration (Tmax) of AMG 786
Day 1 through end of study (approximately 40 days)
Area Under the Concentration-time Curve (AUC) of AMG 786
Day 1 through end of study (approximately 40 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Single Ascending Dose CohortsEXPERIMENTALParticipants in 4 cohorts will receive either AMG 786 or placebo in Single Ascending Doses.
Part A: Food Effect CohortEXPERIMENTALParticipants 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 CohortsEXPERIMENTALParticipants in 4 cohorts will receive either AMG 786 or placebo in Multiple Ascending Doses.

Interventions

NameTypeDescription
AMG 786DRUGOral tablet
PlaceboOTHEROral tablet
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

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...

Countries:United States
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Frequently asked questions about AMG 786

What is AMG 786 used for?

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.

Who makes AMG 786?

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.

What phase is AMG 786 in?

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.

What clinical trials is AMG 786 in?

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.

Is AMG 786 FDA approved?

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.