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Status:

COMPLETED

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

Lead Sponsor:

Amgen

Conditions:

Non-alcoholic Fatty Liver Disease

Eligibility:

All Genders

18-70 years

Phase:

PHASE1

Brief Summary

This study aims to assess the safety and tolerability of AMG 609 when administered subcutaneously as single doses in participants with non-alcoholic fatty liver disease (NAFLD).

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Men and women age ≥ 18 to ≤ 70 years of age at the time of signing the informed consent
  • Body mass index (BMI) of ≥ 27 kg/m2 to ≤ 45.0 kg/m2
  • Liver steatosis, measured by MRI-PDFF, greater than 8%
  • Exclusion Criteria
  • 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)
  • Uncontrolled diabetes (HgbA1c \> 9%) or uncontrolled hypertension.
  • History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers occurring more than 5 years prior to randomization or 3 years prior to randomization for basal cell carcinoma.
  • Females of reproductive potential.

Exclusion

    Key Trial Info

    Start Date :

    May 24 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 19 2023

    Estimated Enrollment :

    47 Patients enrolled

    Trial Details

    Trial ID

    NCT04857606

    Start Date

    May 24 2021

    End Date

    July 19 2023

    Last Update

    November 7 2023

    Active Locations (10)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (10 locations)

    1

    The Institute for Liver Health - Arizona Liver Health

    Chandler, Arizona, United States, 85224

    2

    ProSciento Incorporated

    Chula Vista, California, United States, 91911

    3

    Catalina Research Institute

    Montclair, California, United States, 91763

    4

    Inland Empire Liver Foundation

    Rialto, California, United States, 92377