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AMG 732

Phase 2

Thyroid Eye Disease | Small molecule | Endocrine |Amgen Inc.|Last Updated: May 26, 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_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment118
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07438405An Open-label, Rollover Trial to Evaluate the Efficacy and Safety of AMG 732 in Participants With Thyroid Eye DiseasePHASE2 RECRUITING 30 — — May 7, 2026Jul 14, 2028May 26, 20261 United States
NCT06401044A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye DiseasePHASE1 RECRUITING 88 — — May 30, 2024Aug 13, 2027May 15, 202634 United States, Australia +10
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Study Endpoints
Primary Endpoints
Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who are Defined as Primary Nonresponders or Relapsed During the Safety Follow-up in the Parent Trial
Week 24

Responders are defined as participants with a ≥ 2 mm reduction from baseline in the trial eye without deterioration (≥ 2 mm increase) of proptosis in the fellow eye.

Part A: Number of Participants With Treatment-emergent Adverse Events
Day 1 through Week 36 (End of Study)
Part B: Change from Baseline in Proptosis Measurement by an Exophthalmometer in the Study Eye
Baseline to End of Treatment (EoT) (approximately 6 Months)
Secondary Endpoints
Change from Baseline at Week 24 in Proptosis Measurement by an Exophthalmometer in the Trial Eye in Participants with TED who are Defined as Primary Nonresponders or Relapsed During the Safety Follow-up in the Parent Trial
Baseline and Week 24
Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who had Relapse after Achieving Proptosis Response in the Parent Trial
Week 24
Change from Baseline at Week 24 in Proptosis Measurement by an Exophthalmometer in the Trial Eye in Participants with TED who had Relapse after Achieving Proptosis Response in the Parent Trial
Baseline and Week 24
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AMG 732EXPERIMENTALParticipants will receive AMG 732 subcutaneously (SC)
Part A: AMG 732EXPERIMENTALParticipants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).
Part A: PlaceboPLACEBO_COMPARATORParticipants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).
Part B: AMG 732 Low DoseEXPERIMENTALParticipants will receive AMG 732 low dose SC.
Part B: AMG 732 Medium DoseEXPERIMENTALParticipants will receive AMG 732 medium dose SC.
Part B: AMG 732 High DoseEXPERIMENTALParticipants will receive AMG 732 high dose SC.
Part B: PlaceboPLACEBO_COMPARATORParticipants will receive placebo SC.
Interventions
NameTypeDescription
AMG 732DRUGAMG 732 will be administered SC.
PlaceboOTHERSC injection
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria 1. Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Age ≥ 18 years at the time of signing informed consent for parent trial. 3. Moderate-to-severe TED at the time of enrollm...

Countries:United StatesAustraliaCanadaFranceGermanyGreeceItalyJapanPolandSingaporeSpainTaiwan
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Recent Changes (Last 90 Days)
LOWMay 27, 2026NCT07438405Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 27, 2026NCT07438405Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 26, 2026NCT06401044primaryCompletionDate: changed
LOWMay 26, 2026NCT07438405primaryCompletionDate: changed
LOWMay 24, 2026NCT06401044studyFirstPostDate: changed
LOWMay 24, 2026NCT07438405studyFirstPostDate: changed