Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-29 @ 4:27 PM
Study NCT ID:
NCT04857606
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2021-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease
Sponsor:
Amgen
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: