← Back to Search

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
1,370 Previous Clinical Trials
1,377,641 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
924,084 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research require participants to be over a certain age?

"The age restriction for this clinical trial is 18-70 years old, while 33 medical studies are open to minors and 321 trials target the senior population."

Answered by AI

Has AMG 609 earned the official sanction of the FDA?

"Due to the limited data regarding AMG 609's efficacy and safety, our team at Power rated it a 1 on the scale of 1-3."

Answered by AI

Are there any qualifications that would exclude me from participating in this research?

"This clinical research is seeking 106 volunteers with nonalcoholic steatohepatitis between 18-70 years old. Most importantly, potential candidates must have a BMI of 27 to 45 kg/m2."

Answered by AI

Are new participants being taken for this research program?

"Affirmative. The trial, which was first advertised on May 24th 2021 and had its last update on September 28th 2022, is still actively recruiting participants according to the data available on clinicaltrials.gov. At present, 106 volunteers are needed from 8 sites in total."

Answered by AI

What is the current sample size for this experimental treatment?

"To fill this clinical trial, 106 participants who satisfy the requisite criteria must be enrolled. In two different states - Virginia and Arizona - ProSciento Inc. in Chula Vista and McGuire VA Medical Center in Richmond are both offering access to the study."

Answered by AI

What is the number of hospitals conducting this investigation currently?

"This study is conducted in 8 different medical centres, including ProSciento, Inc. in Chula Vista, McGuire VA Medical Center in Richmond and The Institute for Liver Health - Arizona Liver Health in Chandler among them."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Just getting help.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease
2021. "Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04857606.
~12 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top