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Monoclonal Antibodies

AMG 609 for 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 day 1 to day 150
Awards & highlights

Study Summary

This trial is testing a new drug for safety and how well it works in people with non-alcoholic fatty liver disease.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 150
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 150 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)
Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes
Subject Incidence of Clinically Significant Change from Baseline in Vital Signs
+1 more
Secondary outcome measures
Area Under the Concentration Time Curve (AUC) of AMG 609
Maximum Observed Concentration (Cmax) of AMG 609
Time to Maximum Observed Concentration (Tmax) of AMG 609

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
1,382 Previous Clinical Trials
1,379,636 Total Patients Enrolled
MDStudy DirectorAmgen
928 Previous Clinical Trials
926,683 Total Patients Enrolled
~12 spots leftby May 2025
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