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AMG 127

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Amgen Inc.|Last Updated: May 15, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment162
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07590193A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes MellitusPHASE1 NOT YET_RECRUITING 162Jun 15, 2026Oct 2, 2027May 15, 2026 -
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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)
Incidence and 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 — 75 Years
SexALL
Healthy VolunteersYes

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...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07590193primaryCompletionDate: changed
LOWMay 24, 2026NCT07590193studyFirstPostDate: changed
LOWMay 21, 2026NCT07590193NEW_TRIAL: changed
LOWMay 21, 2026NCT07590193NEW_TRIAL: changed