Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicentre, randomized, placebo-controlled trial to assess the efficacy and safety of dapagliflozin on improving non-alcoholic steatohepatitis as determined by liver biopsies and metabolic risk factors.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin group | Experimental | Participants will receive dapagliflozin 10mg po qd. |
|
| Placebo group | Placebo Comparator | Participants will receive placebo po qd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Participants will receive dapagliflozin 10mg po qd |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in scored liver histological improvement over 12 months | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of NASH | defined as a hepatocellular ballooning score of 0, and lobular inflammation score of 0 or 1) without worsening of fibrosis | Baseline to 12 months |
| Improvement of fibrosis | defined as reduction in fibrosis of at least 1 stage) without worsening of NASH |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Huijie Zhang, MD.PhD. | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40467095 | Derived | Lin J, Huang Y, Xu B, Gu X, Huang J, Sun J, Jia L, He J, Huang C, Wei X, Chen J, Chen X, Zhou J, Wu L, Zhang P, Zhu Y, Xia H, Wen G, Liu Y, Liu S, Zeng Y, Zhou L, Jia H, He H, Xue Y, Wu F, Zhang H. Effect of dapagliflozin on metabolic dysfunction-associated steatohepatitis: multicentre, double blind, randomised, placebo controlled trial. BMJ. 2025 Jun 4;389:e083735. doi: 10.1136/bmj-2024-083735. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C529054 | dapagliflozin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Participants will receive placebo po qd |
|
| Baseline to 12 months |
| Change in fibrosis score | Baseline to 12 months |
| Change in each component score in the NAS | Baseline to 12 months |
| Change in body weight | Baseline to 12 months |
| Change in waist circumference | Baseline to 12 months |
| Change in visceral fat | Baseline to 12 months |
| Change in liver fat | Baseline to 12 months |
| Change in HbA1C | Baseline to 12 months |
| Change in blood pressure | Baseline to 12 months |
| Change in serum lipids | Baseline to 12 months |
| Change in insulin resistance | Baseline to 12 months |
| Change in inflammatory markers of NASH | Baseline to 12 months |
| Change in health related quality of life scores (SF-36) | Baseline to 12 months |