Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

Inclusion Criteria:

• Participant is a male or female, aged ≥18 and ≤65 years.

• Participant is newly diagnosed with MB leprosy and has been receiving MDT ≤ 28 days.

• Participant is willing and able to give informed consent for participation in thetrial.

• Participant is willing to adhere to study follow-up schedule for 48 weeks.

Exclusion Criteria:

• Participant has received MDT >28 days for the current episode of MB leprosy, priorto study enrolment.

• Presence of leprosy reaction and/or nerve function impairment requiring systemiccorticosteroids on screening/enrolment evaluation.

• Participants who have been treated for leprosy in the past.

• Chronic systemic corticosteroid use for any other medical condition on screeningevaluation (chronic use defined as ≥ 2 weeks).

• History of diabetes mellitus or diabetes mellitus diagnosed on screening evaluation (random blood glucose is elevated ≥200 mg/dL (or ≥11,1 mmol/L) or fasting bloodglucose ≥ 126 mg/dL (or ≥7.0 mmol/L)).

• History of hypoglycaemia (random blood glucose <55 mg/dL (or <3.0 mmol/L).

• History of cardiac failure, ischaemic heart disease, alcoholism, history of lacticacidosis or states associated with lactic acidosis such as shock or pulmonaryinsufficiency, and conditions associated with hypoxia.

• History of intolerance or hypersensitivity to metformin.

• Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m2 calculated by theCKDEPI equation.

• AST or ALT ≥3 times the upper limit of normal (ULN) on screening evaluation.

• Any serious medical condition for which participation in the trial, as judged by theinvestigator or treating physician, could compromise the well-being of the subjector prevent, limit or confound protocol-specified assessments.

• HIV-positive on screening evaluation.

• Female participant of childbearing age who is pregnant (clinically confirmed orurine dipstick for human chorionic gonadotrophin hormone) or breastfeeding.

• Use of metformin within 12 weeks prior to study enrolment.

• Use of other regular hypoglycaemic agents, including insulin.

• Participation in another research trial involving an investigational product within 12 weeks prior to study enrolment.