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AMG 609 for Non-alcoholic Fatty Liver Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Translational Clinical Research LLC, Aventura, FLNon-alcoholic Fatty Liver DiseaseAMG 609 - Drug
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Intervention/ Drug
1
LY3849891
1
Guselkumab 100mg

Study Objectives

5 Primary · 4 Secondary · Reporting Duration: Day 1 to Day 150

Baseline to Day 113
Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)
Baseline to Day 150
Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes
Subject Incidence of Clinically Significant Change from Baseline in Vital Signs
Baseline to Week 12
Achievement of Greater than or Equal to 30 Percent (%) Relative Reduction of Liver Fat at 12 Weeks as Measured by MRI-PDFF
Relative Change (Percentage [%]) in Liver Fat at 12 Weeks as Measured by Magnetic Resonance Imaging Derived Proton Density Fat Fraction (MRI-PDFF)
Day 150
Subject Incidence of Treatment-emergent Adverse Events
Up to Day 150
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 Safety

Safety Progress

1 of 3

Similar Trials

1
Intervention/ Drug
1
LY3849891
1
Guselkumab 100mg

Trial Design

2 Treatment Groups

AMG 609
1 of 2
Placebo
1 of 2

Experimental Treatment

56 Total Participants · 2 Treatment Groups

Primary Treatment: AMG 609 · Has Placebo Group · Phase 1

AMG 609
Drug
Experimental Group · 1 Intervention: AMG 609 · Intervention Types: Drug
Placebo
Drug
Experimental Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2640

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to day 150

Who is running the clinical trial?

AmgenLead Sponsor
1,301 Previous Clinical Trials
1,330,121 Total Patients Enrolled
MDStudy DirectorAmgen
843 Previous Clinical Trials
899,414 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your body mass index (BMI) is between 27 and 45.

Who else is applying?

What state do they live in?
Florida100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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