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

Phase 1

Completed

• Conditions: Non-alcoholic Fatty Liver Disease
• Interventions: Drug: Placebo; Drug: AMG 609

• Registration Number: NCT04857606
• Lead Sponsor: Amgen

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-23
• Study Start: 2021-05-24
• Primary Completion: 2023-07-19
• Study Completion: 2023-07-19
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive the matching placebo.
AMG 609	AMG 609	Up to 7 cohorts ranging by various dose levels.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Time to Maximum Observed Concentration (Tmax) of AMG 609	Up to Day 150

Trial Locations

Locations (10)

Orange County Research Center; 🇺🇸 Tustin, California, United States

ProSciento Incorporated; 🇺🇸 Chula Vista, California, United States

The Institute for Liver Health - Arizona Liver Health; 🇺🇸 Chandler, Arizona, United States

Catalina Research Institute; 🇺🇸 Montclair, California, United States

Inland Empire Liver Foundation; 🇺🇸 Rialto, California, United States

Translational Clinical Research LLC; 🇺🇸 Aventura, Florida, United States

Endeavor Clinical Trials; 🇺🇸 San Antonio, Texas, United States

Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States

Pinnacle Clinical Research; 🇺🇸 San Antonio, Texas, United States

McGuire VA Medical Center; 🇺🇸 Richmond, Virginia, United States