NCT05243654: MetLep

Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

Recruiting now Phase 2 Last updated 7 August 2025

What this trial tests

Phase 2 trial testing Metformin in Leprosy in 166 participants. Currently enrolling.

Timeline

1 October 2022

Primary endpoint
31 August 2026

30 September 2026

Quick facts

Lead sponsor	Oxford University Clinical Research Unit Indonesia
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	166
Start date	1 October 2022
Primary completion	31 August 2026
Estimated completion	30 September 2026
Sites	6 locations across Indonesia

Drugs / interventions tested

• Metformin (metformin) — full drug profile →
• Placebo

Conditions studied

• Leprosy — all drugs for Leprosy →
• Leprosy, Multibacillary — all drugs for Leprosy, Multibacillary →
• Neglected Tropical Diseases — all drugs for Neglected Tropical Diseases →

Sponsor

Oxford University Clinical Research Unit Indonesia

Who can join

Adults 18 to 65, any sex, with Leprosy or Leprosy, Multibacillary. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Metformin as adjunctive therapy in combination with multidrug treatment for multibacillary leprosy: A protocol for a randomized double-blind, controlled Phase 2 trial in Indonesia (MetLep Trial).
   Krismawati H, Muchtar SV, Rahardjani M, Utami NN, et al · · 2023 · cited 7× · PMID 38808319 · DOI 10.12688/wellcomeopenres.19455.2
2. Challenges associated with dapsone for leprosy treatment in Indonesia - urgent need for access to alternative antimicrobial drugs.
   Krismawati H, Harianja M, Oktavian A, Bøgh C, et al · · 2025 · cited 3× · PMID 40084155 · DOI 10.1016/j.lansea.2025.100555
3. The unbreakable journey: using photovoice to raise awareness and fight leprosy stigma in Papua, Indonesia.
   Dien R, Krismawati H, Ayomi I, Timoria D, et al · · 2023 · cited 3× · PMID 36866652 · DOI 10.1093/bjd/ljad059
4. Exploring leprosy perceptions in South Sulawesi, Indonesia: A mixed-methods study on knowledge, attitudes, practices, and stigma.
   Limato R, Sutrisni IA, Sagara R, Abdillah AF, et al · · 2025 · PMID 41452835 · DOI 10.1371/journal.pgph.0005675
5. Metformin as adjunctive therapy in combination with multidrug treatment for multibacillary leprosy: A protocol for a randomized double-blind, controlled Phase 2 trial in Indonesia (MetLep Trial)
   Krismawati H, Muchtar SV, Rahardjani M, Utami NN, et al · · 2024 · DOI 10.12688/wellcomeopenres.19455.2