47 Participants Needed

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

Recruiting at 10 trial locations
AC
Overseen ByAmgen Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

Inclusion Criteria

Liver steatosis, measured by MRI-PDFF, greater than 8%
Your body mass index (BMI) falls between 27 and 45, inclusive.

Exclusion Criteria

You have a history of cancer, except for non-invasive cervical cancer or non-melanoma skin cancer that was removed more than 5 years ago (or 3 years ago for basal cell skin cancer).
Evidence of other liver disease (eg, viral hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, autoimmune chronic hepatitis, Wilson's disease, alpha-1 anti-trypsin deficiency, haemochromatosis, drug-induced liver injury, bile duct obstruction, known or suspected hepatocellular carcinoma).
Significantly elevated LFTs (more than 1.5x ULN)
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of AMG 609 or placebo subcutaneously

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and tolerability after receiving the dose

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • AMG 609
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

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