Skip to main content
OpenTrials
Completed

NCT Number: NCT04857606

Single Ascending Dose of AMG 609 in Participants 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Institute for Liver Health - Arizona Liver Health, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

AMG 609

Drug

Single dose of AMG 609 administered as a subcutaneous injection.

Placebo

Drug

Single dose of placebo administered as a subcutaneous injection.

Primary outcomes

  1. Subject Incidence of Treatment-emergent Adverse Events

    Time frame: Day 1 to Day 150

  2. Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes

    Time frame: Baseline to Day 150

  3. Subject Incidence of Clinically Significant Change from Baseline in Vital Signs

    Time frame: Baseline to Day 150

  4. Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)

    Time frame: Baseline to Day 113

Secondary outcomes

  1. Maximum Observed Concentration (Cmax) of AMG 609

    Time frame: Up to Day 150

  2. Time to Maximum Observed Concentration (Tmax) of AMG 609

    Time frame: Up to Day 150

  3. Area Under the Concentration Time Curve (AUC) of AMG 609

    Time frame: Up to Day 150

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 23, 2021
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.