SGLT2i to Prevent of Liver Complications in Patients With CHB and Diabetes Mellitus

This is a five-year, double blinded, randomised trial of dapagliflozin versus placebo in patients with chronic hepatitis B and DM or IFG complicated with compensated advanced chronic liver disease (cACLD). 412 subjects will be recruited. Subject will be randomly assigned to receive dapagliflozin 10mg daily or dapagliflozin placebo one tablet daily for up to 5 years. After randomization, subject will be followed up at month 3, month 6 and then 6-monthly until 60 months (follow up ± 4 weeks from scheduled clinic visit is allowed). At each visit, drug compliance, physical examination, observed or reported adverse events will be assessed. 10ml of blood will be taken at each visit and transient elastography to assess fibrosis regression will be performed at 60th month or at withdrawal visit. You are discouraged to use (pegylated)-interferon, any other NA including lamivudine, adefovir, and telbivudine, another SGLT2i Empagliflozin (Jardiance), Dapagliflozin + Metformin XR (Xigduo).

NCT Number	NCT06364930
Lead Sponsor	Chinese University of Hong Kong
Conditions	Chronic Hepatitis B
Enrollment	412 participants
Start Date	2024-03-26
Primary Completion	2030-10-31 (estimated)
Study Completion	2031-03-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-18