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
Overview
- Phase
- Phase 1
- Intervention
- AMG 609
- Conditions
- Non-alcoholic Fatty Liver Disease
- Sponsor
- Amgen
- Enrollment
- 47
- Locations
- 10
- Primary Endpoint
- Subject Incidence of Treatment-emergent Adverse Events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
AMG 609
Up to 7 cohorts ranging by various dose levels.
Intervention: AMG 609
Placebo
Participants will receive the matching placebo.
Intervention: Placebo
Outcomes
Primary Outcomes
Subject Incidence of Treatment-emergent Adverse Events
Time Frame: Day 1 to Day 150
Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes
Time Frame: Baseline to Day 150
Subject Incidence of Clinically Significant Change from Baseline in Vital Signs
Time Frame: Baseline to Day 150
Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)
Time Frame: Baseline to Day 113
Secondary Outcomes
- 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)