| Trial ID: | L0257 |
| Source ID: | NCT03723252
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
Dapagliflozin Efficacy and Action in NASH
|
| Acronym: |
DEAN
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: Dapagliflozin|Drug: Placebo
|
| Outcome Measures: |
Improvement in scored liver histological improvement over 12 months|Resolution of NASH|Change in fibrosis score|Change in each component score in the NAS|Change in body weight|Change in waist circumference|Change in visceral fat|Change in liver fat|Change in HbA1C|Change in blood pressure|Change in serum lipids|Change in insulin resistance|Change in inflammatory markers of NASH|Change in health related quality of life scores (SF-12)
|
| Sponsor/Collaborators: |
Nanfang Hospital of Southern Medical University
|
| Gender: |
All
|
| Age: |
18 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Phase 3
|
| Enrollment: |
100
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
March 20, 2019
|
| Completion Date: |
June 2022
|
| Results First Posted: |
--
|
| Last Update Posted: |
June 22, 2021
|
| Locations: |
Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, China
|
| URL: |
https://ClinicalTrials.gov/show/NCT03723252
|
