| Trial ID: | L0006 |
| Source ID: | NCT04857606
|
| Associated Drug: |
AMG 609
|
| Title: |
Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: AMG 609|Drug: Placebo
|
| 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)|Relative Change (Percentage [%]) in Liver Fat at 12 Weeks as Measured by Magnetic Resonance Imaging Derived Proton Density Fat Fraction (MRI-PDFF)|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|Achievement of Greater than or Equal to 30 Percent (%) Relative Reduction of Liver Fat at 12 Weeks as Measured by MRI-PDFF
|
| Sponsor/Collaborators: |
Amgen
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
106
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Basic Science
|
| Start Date: |
May 24, 2021
|
| Completion Date: |
May 7, 2023
|
| Results First Posted: |
--
|
| Last Update Posted: |
December 27, 2021
|
| Locations: |
Orange County Research Center, Tustin, California, United States|Translational Clinical Research LLC, Aventura, Florida, United States|Texas Liver Institute, San Antonio, Texas, United States|Endeavor Clinical Trials, San Antonio, Texas, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT04857606
|
