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).

Study Overview

• Status: Completed
• Conditions: Non-alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: AMG 609; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • The Institute for Liver Health - Arizona Liver Health
  • California
    • Chula Vista, California, United States, 91911
      • ProSciento Incorporated
    • Montclair, California, United States, 91763
      • Catalina Research Institute
    • Rialto, California, United States, 92377
      • Inland Empire Liver Foundation
    • Tustin, California, United States, 92780
      • Orange County Research Center
  • Florida
    • Aventura, Florida, United States, 33180
      • Translational Clinical Research LLC
  • Texas
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials
    • San Antonio, Texas, United States, 78215
      • Texas Liver Institute
    • San Antonio, Texas, United States, 78229
      • Pinnacle Clinical Research
  • Virginia
    • Richmond, Virginia, United States, 23249
      • McGuire VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo; Participants will receive the matching placebo.	Drug: Placebo; Single dose of placebo administered as a subcutaneous injection.
Experimental: AMG 609; Up to 7 cohorts ranging by various dose levels.	Drug: AMG 609; Single dose of AMG 609 administered as a subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Concentration (Cmax) of AMG 609	Up to Day 150
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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2021
• Primary Completion (Actual): July 19, 2023
• Study Completion (Actual): July 19, 2023

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: NAFLD; Single ascending dose; AMG 609
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 20200001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No