| Trial ID: | L0379 |
| Source ID: | NCT05006885
|
| Associated Drug: |
ALT-801
|
| Title: |
A Phase 1, 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-Alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: ALT-801;Other: Placebo
|
| Outcome Measures: |
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)Change from baseline in liver fat fraction by MRI-PDFF;Change from baseline in body weight;Change from baseline in waist circumference;Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions);Change from baseline in hemoglobin A1c;Change from baseline in adiponectin;Change from baseline in inflammatory markers (C-reactive protein);Change from baseline in fibrosis markers (Pro-C3)
|
| Sponsor/Collaborators: |
Altimmune, Inc.
|
| Gender: |
All
|
| Age: |
18 Years65 Years
|
| Phases: |
Phase 1
|
| Enrollment: |
72
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
| Start Date: |
30/07/2021
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
21 February 2022
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05006885
|
