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AMG 609

Phase 1

Non-alcoholic Fatty Liver Disease | Small molecule | Metabolic |Amgen Inc.|Last Updated: Nov 7, 2023

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-BlindCONTROLLED
Total Trials1
Total Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04857606Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver DiseasePHASE1 COMPLETED 47 — — May 24, 2021Jul 19, 2023Nov 7, 202310 United States
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Study Endpoints
Primary Endpoints
Subject Incidence of Treatment-emergent Adverse Events
Day 1 to Day 150
Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes
Baseline to Day 150
Subject Incidence of Clinically Significant Change from Baseline in Vital Signs
Baseline to Day 150
Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)
Baseline to Day 113
Secondary Endpoints
Maximum Observed Concentration (Cmax) of AMG 609
Up to Day 150
Time to Maximum Observed Concentration (Tmax) of AMG 609
Up to Day 150
Area Under the Concentration Time Curve (AUC) of AMG 609
Up to Day 150
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AMG 609EXPERIMENTALUp to 7 cohorts ranging by various dose levels.
PlaceboEXPERIMENTALParticipants will receive the matching placebo.
Interventions
NameTypeDescription
AMG 609DRUGSingle dose of AMG 609 administered as a subcutaneous injection.
PlaceboDRUGSingle dose of placebo administered as a subcutaneous injection.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites10

* Inclusion Criteria * Men and women age ≥ 18 to ≤ 70 years of age at the time of signing the informed consent * Body mass index (BMI) of ≥ 27 kg/m2 to ≤ 45.0 kg/m2 * Liver steatosis, measured by MRI-PDFF, greater than 8% * Exclusion Criteria * Evidence of other liver disease (eg, viral he...

Countries:United States
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