🏛️ Verified NIH Record • Updated 2026-06-12
Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL (NCT05164341)
🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Chiesi Farmaceutici S.p.A.
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (4 items).
Location: University of Alabama — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Previous treatment with metreleptin
- Leptin levels \>20.0 ng/mL
- Acquired or radiation induced partial lipodystrophy (APL) Other protocol defined inclusion/exclusion criteria apply
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (31 Sites)
- University of Alabama — Birmingham, Alabama
- UC Davis — Sacramento, California
- Flourish Boca Raton — Boca Raton, Florida
- Emory University — Atlanta, Georgia
- Massachusetts General Hospital — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Mayo Clinic — Rochester, Minnesota
- University of Missouri — Columbia, Missouri
- Amryt Research Site, Endocrinology Research Associates Inc — Columbus, Ohio
- The Ohio State University Wexner Medical Center — Columbus, Ohio
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- UT Southwestern Medical Center — Dallas, Texas
- Medical College of Wisconsin — Milwaukee, Wisconsin
- UZ Leuven — Leuven,
- Universitário Walter Cantídio — Fortaleza,
- Insight Centro de Pesquisas — Porto Alegre,
- Hospital das Clinicas FMRP-USP — Ribeirão Preto,
- Instituto Estadual de Diabetes e Endocrinologia (IEDE-RJ) — Rio de Janeiro,
- Nova Scotia Health — Halifax, Nova Scotia
- Care Access Clinic — Sydney, Nova Scotia
- Hamilton General Hospital- McMaster University — Hamilton, Ontario
- London Health Science Centre — London, Ontario
- Ecogene-21 — Chicoutimi, Quebec
- Faculty of Medicine, Universite Laval — Québec, Quebec
- Universidad Catolica — Santiago,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.