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

• Status: Recruiting
• Trial end date: 2022-12-15
• Target enrollment: 0
• Participant gender: All

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) and to assess change in liver fat (expansion cohort only).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

• 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 ≤ 40.0 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 > 8%) 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.