Evaluation of the therapeutic effect of the SGLT-2 inhibitor dapagliflozin on non-alcoholic fatty liver disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300073720

Enrollment

Unknown

Registered

2023-07-19

Start date

2023-08-01

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-alcoholic fatty liver disease

Interventions

dapagliflozin group:Patients received dapaglifozin 10 mg once daily for 3 months

Placebo group:Patients received placebo once daily for 3 months

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients were included if they were .18 years of age, had documented hepatic steatosis ( ultrasonography confirmation ),

Exclusion criteria

Exclusion criteria: Exclusion criteria were highly uncontrolled diabetes (HbA1c > 10.0%); alcohol intake > 30 g/day (three drinks per day) within the previous 10 years or > 10 g/day within the previous year; evidence of other forms of liver disease, including hepatitis B (positive serum hepatitis B surface antigen), hepatitis C (positive antihepatitis C virus), autoimmune hepatitis (positive autoimmune serology ), drug-induced liver disease on the basis of exposure and history, and biliary duct obstruction on the basis of imaging studies; history of gastrointestinal bypass or use of drugs known to cause hepatic steatosis (e.g., amiodarone, valproate, tamoxifen, methotrexate, steroids); initiation or change of antidiabetic drugs that influence liver fat, including thiazolidinediones and glucagon-like peptide 1 receptor agonists, or initiation of any SGLT-2 inhibitor, within 90 days prior to randomization; evidence of cirrhosis (on basis of ultrasonography or hepatocellular carcinoma (evidence on MRI); pregnant or trying to become pregnant; renal insufficiency (glomerular filtration rate ,90 mL/min/1.73 m2 as estimated by the MDRD equation); contraindications to dapagliflozin use (history of recurrent urinary tract or genital infections, or known allergy to the molecule);

Design outcomes

Primary

Measure	Time frame
liver to spleen attenuation ratio;visceral fat areas;subcutaneous fat areas;	—

Secondary

Measure	Time frame
NASLD fibrosis score;fibrosis4;NAFIC score;	—

Countries

China

Contacts

Public ContactLan Cheng

Jiangxi Provincial People's Hospital

471907791@qq.com+86 189 9560 0983

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026