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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 609 in Subjects With Non-alcoholic Fatty Liver Disease

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).

• 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.