drugset / Trial / NCT03723252

Dapagliflozin Efficacy and Action in NASH

NCT03723252 ↗

Phase 3 Completed 154 enrolled Nanfang Hospital, Southern Medical University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2019-03-20
Primary completion
2024-03-22
Completion
2024-03-28

Outcome

Met primary endpoint

paper 53% (41/78) of participants in the dapagliflozin group and 30% (23/76) in the placebo group (risk ratio 1.73 (95% confidence interval (CI) 1.16 to 2.58); P=0.006). PMID 40467095 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapagliflozin Small molecule 10 mg Oral