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Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

Study acronym: MetLep
StatusRecruiting
PhasePhase 2
Started
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Record status
This record was last updated August 7, 2025 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Aug 31, 2025 to Aug 31, 2026
    • Study sites: 5 to 6
    • Study completion date: Feb 28, 2026 to Sep 30, 2026
    • Eligibility criteria expanded, about 3 words
    v6
  2. Study sites: 3 to 5v5
  3. Study description expanded, about 14 wordsv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Aug 1, 2022 to Oct 1, 2022
    v3
  5. Start date: Jun 1, 2022 to Aug 1, 2022
    • Eligibility criteria shortened, about 24 words
    • Study description revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Leprosy, Leprosy, Multibacillary, Neglected Tropical Diseases
Related terms Leprosy, Leprosy, Multibacillary, Neglected Diseases
Enrollment 166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov