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

Amgen

Status and phase

Completed

Phase 1

Conditions

Non-alcoholic Fatty Liver Disease

Treatments

Drug: Placebo

Drug: AMG 609

Study type

Interventional

Funder types

Industry

Identifiers

NCT04857606

20200001

Details and patient eligibility

About

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).

Enrollment

47 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 ≤ 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.