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AMG 609

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

AMG 609 · 1 trial · 1 indication

Phase 1 1
NCT04857606Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver DiseaseNon-alcoholic Fatty Liver Disease
COMPLETED47 Analytics
PHASE1COMPLETED
Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease
Non-alcoholic Fatty Liver DiseaseUnlock trial analytics

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 to 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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Frequently asked questions about AMG 609

What is AMG 609 used for?

AMG 609 is an investigational small molecule being developed for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD). It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with NAFLD to evaluate its safety and tolerability.

Who makes AMG 609?

AMG 609 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 Non-alcoholic Fatty Liver Disease.

What phase is AMG 609 in?

AMG 609 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 trial of AMG 609 in participants with Non-alcoholic Fatty Liver Disease has been completed.

What clinical trials is AMG 609 in?

AMG 609 has one completed clinical trial, NCT04857606, titled 'Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease.' This Phase 1 study enrolled 47 participants in the United States and evaluated the drug in patients with NAFLD.

Is AMG 609 the same as any other drug?

AMG 609 is the investigational name for this drug candidate developed by Amgen. No alternative names have been reported for this compound. It is being studied under the clinical trial identifier NCT04857606 for Non-alcoholic Fatty Liver Disease.