MedTrace Logo

Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

NCT05243654 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2025-08-07

No results posted yet for this study

Summary

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.

Conditions

  • Leprosy
  • Leprosy, Multibacillary
  • Neglected Tropical Diseases

Interventions

DRUG

Metformin

Metformin 1000mg XR OD + standard-of-care MDT

DRUG

Placebo

Placebo + standard-of-care MDT

Sponsors & Collaborators

  • University of Gadjah Mada, Faculty of Medicine

    collaborator UNKNOWN

  • University of Diponegoro

    collaborator UNKNOWN

  • Papua Agency of Health Research and Development (NIHRD)

    collaborator UNKNOWN

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • Oxford University Clinical Research Unit

    collaborator UNKNOWN

  • Oxford University Clinical Research Unit Indonesia

    lead OTHER

Principal Investigators

  • Hardiyanto Soebono, Prof.Dr.dr · Center of Tropical Medicine, University of Gadjah Mada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2026-08-31
Completion
2026-09-30

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05243654 on ClinicalTrials.gov