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

Primary Purpose

Non-alcoholic Fatty Liver Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AMG 609
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Non-alcoholic Fatty Liver Disease focused on measuring Single ascending dose, NAFLD, AMG 609

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  • 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.

Sites / Locations

  • The Institute for Liver Health - Arizona Liver Health
  • ProSciento Incorporated
  • Catalina Research Institute
  • Inland Empire Liver Foundation
  • Orange County Research Center
  • Translational Clinical Research LLC
  • Texas Liver Institute
  • Endeavor Clinical Trials
  • Pinnacle Clinical Research
  • McGuire VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

AMG 609

Placebo

Arm Description

Up to 7 cohorts ranging by various dose levels.

Participants will receive the matching placebo.

Outcomes

Primary Outcome Measures

Subject Incidence of Treatment-emergent Adverse Events
Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes
Subject Incidence of Clinically Significant Change from Baseline in Vital Signs
Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)

Secondary Outcome Measures

Maximum Observed Concentration (Cmax) of AMG 609
Time to Maximum Observed Concentration (Tmax) of AMG 609
Area Under the Concentration Time Curve (AUC) of AMG 609

Full Information

First Posted
April 21, 2021
Last Updated
October 10, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04857606
Brief Title
Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
Keywords
Single ascending dose, NAFLD, AMG 609

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMG 609
Arm Type
Experimental
Arm Description
Up to 7 cohorts ranging by various dose levels.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Participants will receive the matching placebo.
Intervention Type
Drug
Intervention Name(s)
AMG 609
Intervention Description
Single dose of AMG 609 administered as a subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose of placebo administered as a subcutaneous injection.
Primary Outcome Measure Information:
Title
Subject Incidence of Treatment-emergent Adverse Events
Time Frame
Day 1 to Day 150
Title
Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes
Time Frame
Baseline to Day 150
Title
Subject Incidence of Clinically Significant Change from Baseline in Vital Signs
Time Frame
Baseline to Day 150
Title
Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)
Time Frame
Baseline to Day 113
Secondary Outcome Measure Information:
Title
Maximum Observed Concentration (Cmax) of AMG 609
Time Frame
Up to Day 150
Title
Time to Maximum Observed Concentration (Tmax) of AMG 609
Time Frame
Up to Day 150
Title
Area Under the Concentration Time Curve (AUC) of AMG 609
Time Frame
Up to Day 150

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
The Institute for Liver Health - Arizona Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
ProSciento Incorporated
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Catalina Research Institute
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Translational Clinical Research LLC
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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