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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04857606

Enrollment

Registered

2021-04-23

Start date

2021-05-24

Completion date

2023-07-19

Last updated

2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Single ascending dose, NAFLD, AMG 609

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).

Interventions

DRUGAMG 609

Single dose of AMG 609 administered as a subcutaneous injection.

DRUGPlacebo

Single dose of placebo administered as a subcutaneous injection.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
Subject Incidence of Treatment-emergent Adverse Events	Day 1 to Day 150
Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes	Baseline to Day 150
Subject Incidence of Clinically Significant Change from Baseline in Vital Signs	Baseline to Day 150
Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)	Baseline to Day 113

Secondary

Measure	Time frame
Time to Maximum Observed Concentration (Tmax) of AMG 609	Up to Day 150
Area Under the Concentration Time Curve (AUC) of AMG 609	Up to Day 150
Maximum Observed Concentration (Cmax) of AMG 609	Up to Day 150

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026