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

NCT04857606 | Completed Phase 1 FDA Drug

• 1 other identifier: 20200001
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 10

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).

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Single ascending dose; NAFLD; AMG 609

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

Study Arms (2)

AMG 609

EXPERIMENTAL

Up to 7 cohorts ranging by various dose levels.

Drug: AMG 609

Placebo

EXPERIMENTAL

Participants will receive the matching placebo.

Drug: Placebo

Interventions

AMG 609 DRUG

Single dose of AMG 609 administered as a subcutaneous injection.

AMG 609

Placebo DRUG

Single dose of placebo administered as a subcutaneous injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (10)

The Institute for Liver Health - Arizona Liver Health

Chandler, Arizona, 85224, United States

Location

ProSciento Incorporated

Chula Vista, California, 91911, United States

Location

Catalina Research Institute

Montclair, California, 91763, United States

Location

Inland Empire Liver Foundation

Rialto, California, 92377, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Translational Clinical Research LLC

Aventura, Florida, 33180, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

Pinnacle Clinical Research

San Antonio, Texas, 78229, United States

Location

McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 23, 2021
• Study Start: May 24, 2021
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (10)