Jayapura City

Researchers are evaluating the effectiveness, safety, and tolerability of adding metformin to the standard multi-drug therapy (MDT) for patients newly diagnosed with multibacillary leprosy. This double-blind, placebo-controlled Phase 2 trial aims to see if metformin can reduce leprosy reactions, nerve damage, and the need for corticosteroids, while also exploring its effects on immune system markers. The study plans to enroll 166 patients aged 18 to 65 years from leprosy endemic areas in Indonesia. Participants will be randomly assigned to receive either metformin 1000 mg once daily or a placebo for 24 weeks, alongside the standard MDT which continues for 48 weeks. The study compares these two groups to assess how metformin as an additional treatment might influence clinical outcomes. This trial is funded by the Leprosy Research Initiative and follows strict protocols to ensure reliable results. During the 48-week study period, participants will be monitored for leprosy reactions and adverse events, with primary outcomes focused on the proportion experiencing these reactions and side effects. Secondary measures include severity and timing of reactions, the amount of corticosteroids used, and quality of life assessments. Regular evaluations include clinical examinations and safety checks to track the participants' health and treatment adherence throughout the study.