This is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of metformin as add-on to entecavir therapy in patients with chronic hepatitis B.

This is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of metformin as add-on to entecavir therapy in patients with chronic hepatitis B. Patients with chronic hepatitis B who met eligibility criteria were randomly assigned (1:1) to receive either metformin (1000 mg, oral, once a day) or placebo (oral, once a day) for 24 weeks in addition to their ongoing entecavir therapy. Patients and investigators were both blinded to group allocation. The primary outcome, serum HBsAg level (log IU/mL) at weeks 24 and 36, was analysed using a linear mixed-effect model. The intention-to-treat populations were included in primary and safety analyses.

Inclusion Criteria:

• HBeAg-negative chronic hepatitis B
• Ongoing treatment with Entecavir for more than 12 months
• HBV DNA < 500 IU/mL
• Quantitative HBsAg < 3 log IU/mL
• ALT and AST < 2 × upper limit of normal (ULN)
• Agree to take contraceptive measures during participation for women of a fertile age
• Agree not to engage in other clinical trials during participation
• Understand and sign the informed consent form before taking any steps related to this study

Exclusion Criteria:

• Diabetes mellitus
• Alcoholic liver disease
• Drug-induced liver damage
• Autoimmune liver disease
• Decompensated cirrhosis
• Liver cancer
• Liver transplantation
• Pregnant or lactating women
• Other conditions unsuitable for participation

Deidentified individual participant data and full study protocol are available upon reasonable request. Researchers should send it to fswang302@163.com to gain access.

After publication of the study results

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