Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

This trial aims to evaluate the efficacy, tolerability and safety of adjunct metformin added to standard-of-care multi-drug therapy (MDT) in patients with multibacillary leprosy, and explore its effects on immunological endpoints. A double-blind, placebo controlled proof-of-concept trial will be performed in which patients with newly diagnosed multibacillary leprosy will be randomized (1:1) to metformin 1000mg OD versus placebo for 24 weeks in addition to MDT during 48 weeks. The main research question is whether adjunctive metformin, combined with MDT, will improve the clinical outcomes of patients with multibacillary leprosy by mitigating leprosy reactions, thereby reducing nerve damage and corticosteroid use and its associated morbidity. The second aim is to explore whether adjunct metformin, added to MDT, has an acceptable tolerability and safety in patients with multibacillary leprosy.

NCT Number	NCT05243654
Lead Sponsor	Oxford University Clinical Research Unit Indonesia Collaborators: University of Gadjah Mada, Faculty of Medicine, University of Diponegoro, Papua Agency of Health Research and Development (NIHRD), London School of Hygiene and Tropical Medicine, Radboud University Medical Center, Oxford University Clinical Research Unit
Conditions	Leprosy, Leprosy, Multibacillary, Neglected Tropical Diseases
Enrollment	166 participants
Start Date	2022-10-01
Primary Completion	2026-08-31 (estimated)
Study Completion	2026-09-30 (estimated)
Updated on ClinicalTrials.gov	2025-08-07