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AMG 127

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Amgen Inc.|Last Updated: Aug 3, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment162

FDA Designations

No designations recorded

Clinical trial landscape

AMG 127 · 1 trial · 1 indication

Phase 1 1
NCT07590193A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2
RECRUITING162 Analytics
PHASE1RECRUITING
A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
NCT07590193162
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Study Endpoints

Primary Endpoints

Number of Treatment-Emergent Adverse Events (TEAEs)
Part A, SAD: Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Day 1 to end of trial (up to approximately 87 days)
Number of Serious Adverse Events (SAEs)
Part A, SAD: Screening to end of trial (up to approximately 86 days); Part B, MAD: Screening to end of trial (up to approximately 114 days); Part C, PoM: Screening to end of trial (up to approximately 115 days)
Number of Adverse Events Leading to Study Discontinuation
Part A, SAD: Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Day 1 to end of trial (up to approximately 87 days)

Secondary Endpoints

Maximum Concentration (Cmax) of AMG 127
Part A, SAD: Predose on Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Predose on Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Predose on Day 1 to end of trial (up to approximately 87 days)
Area Under the Curve (AUC) of AMG 127
Part A, SAD: Predose on Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Predose on Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Predose on Day 1 to end of trial (up to approximately 87 days)
Severity of Retinal Structural Abnormalities Assessed by Optical Coherence Tomography (OCT) in Participants With Type 2 Diabetes Mellitus
Part A, SAD: Screening to end of trial (up to approximately 86 days); Part B, MAD: Screening to end of trial (up to approximately 114 days); Part C, PoM: Screening to end of trial (up to approximately 115 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Single Ascending Dose (SAD)EXPERIMENTALParticipants will receive single ascending doses of AMG 127 via subcutaneous (SC) injection. One cohort will receive a single dose of AMG 127 as an intravenous (IV) infusion.
Part B: Multiple Ascending Dose (MAD)EXPERIMENTALParticipants will receive multiple ascending doses of AMG 127 via SC injection.
Part C: Proof of Mechanism (PoM)EXPERIMENTALParticipants will receive multiple doses of AMG 127 via SC injection.
PlaceboPLACEBO_COMPARATORParticipants will receive a matching placebo as either a SC injection or as an IV infusion.

Interventions

NameTypeDescription
AMG 127DRUGAMG127 will be administered as either a SC injection or as an IV infusion.
PlaceboDRUGPlacebo will be administered as either a SC injection or as an IV infusion.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria for Part A and B * Participant must be 18-65 years of age * Participant must be overtly healthy Inclusion Criteria for Part C * Participant must be 40-75 years of age * Confirmed diagnoses of T2DM Exclusion Criteria for Part A and B * History of hypotension, syncope, or ortho...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 3, 2026NCT07590193lastUpdatePostDate: changed
LOWAug 3, 2026NCT07590193lastUpdatePostDate: changed
LOWJun 23, 2026NCT07590193Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 23, 2026NCT07590193Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about AMG 127

What is AMG 127 used for?

AMG 127 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated in a clinical trial that includes healthy participants and participants with Type 2 Diabetes Mellitus.

Who makes AMG 127?

AMG 127 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of AMG 127 in participants with Type 2 Diabetes Mellitus.

What phase is AMG 127 in?

AMG 127 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants and is designed to evaluate the drug in healthy volunteers and individuals with Type 2 Diabetes Mellitus.

What clinical trials is AMG 127 in?

AMG 127 is being studied in a Phase 1 clinical trial with the identifier NCT07590193. This trial is titled 'A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus' and is currently recruiting participants in the United States. The study is randomized, double-blind, and placebo-controlled, with an enrollment of 162 participants.

Is AMG 127 FDA approved?

AMG 127 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of Type 2 Diabetes Mellitus. The drug is being evaluated in a clinical trial to assess its safety and tolerability, and it has not yet received regulatory approval for any indication.