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Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL

Study acronym: METRE-PL
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 15, 2026 (before its estimated July 21, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Lead sponsor: Amryt Pharma to Chiesi Farmaceutici S.p.A.v15
  2. Primary completion date: Jun 30, 2025 to Jul 21, 2026 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 65 to confirmed 69 · Completion date: Jan 31, 2026 to Oct 31, 2026 · 1 morev14 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 65 to confirmed 69
    • Completion date: Jan 31, 2026 to Oct 31, 2026
    • Site details revised at 31 of 31 sites
  3. Study sites: 27 to 31v13
  4. Study sites revised (27)v12 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 25 to 27 Eligibility criteria expanded, about 46 wordsv11 Show 1 more changeShow less
    • Eligibility criteria expanded, about 46 words

    See this version in full on ClinicalTrials.gov ↗

Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 15 to 25v10
  2. Eligibility criteria expanded, about 6 wordsv9 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 16 to 15v8
  4. Site details revised at 2 of 16 sitesv7
  5. Site details revised at 4 of 16 sitesv6
  6. Study sites: 1 to 16v5
  7. Study title revisedv4 See this version in full on ClinicalTrials.gov ↗
  8. Enrollment target: 80 to 65 Eligibility criteria expanded, about 2 wordsv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Dec 2021 to Dec 17, 2021v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2021 to Dec 17, 2021
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.
Trial Details
NCT Number NCT05164341
Lead Sponsor Chiesi Farmaceutici S.p.A.
Conditions Partial Lipodystrophy
Enrollment 69 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov