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Monoclonal Antibodies

Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease

Phase 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial is testing the safety of a new injectable drug called AMG 609 in people with non-alcoholic fatty liver disease (NAFLD). The goal is to see if the drug is safe and well-tolerated when given as a single dose.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Participants will receive the matching placebo.
Group II: AMG 609Experimental Treatment1 Intervention
Up to 7 cohorts ranging by various dose levels.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
AMG 609
2021
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,442 Previous Clinical Trials
1,397,697 Total Patients Enrolled
MDStudy DirectorAmgen
980 Previous Clinical Trials
941,453 Total Patients Enrolled
~10 spots leftby Dec 2025