Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-06 @ 7:09 PM
Study NCT ID:
NCT07009860
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2025-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
Sponsor:
Altimmune, Inc.
Organization:
Study Overview
Official Title:
RESTORE TRIAL: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD.
* Pemvidutide: 2.4 mg SC once weekly
* Placebo: Placebo SC once weekly
* Pemvidutide: 2.4 mg SC once weekly
* Placebo: Placebo SC once weekly
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: