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

Recruiting at 10 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Disqualifiers: Other liver diseases, Uncontrolled diabetes, Uncontrolled hypertension, History of malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

47 Participants Needed

Trial Summary

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.

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.

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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)

Timeline

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)

Treatment Details

Interventions

• AMG 609

Participant Groups

Group I: Placebo Experimental Treatment 1 Intervention

Participants will receive the matching placebo.

Group II: AMG 609 Experimental Treatment 1 Intervention

Up to 7 cohorts ranging by various dose levels.

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

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

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