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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Partial Lipodystrophy

In brief

This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.

Key facts

Study ID

NCT05164341

Run by

Chiesi Farmaceutici S.p.A.

People needed

69

Starts

2021-12-17

Expected to finish

2026-10-31

Last updated by the study team

2026-06-15

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Familial Partial Lipodystrophy (FPLD)
• Subjects with poor metabolic control defined as:
• HbA1c ≥7% (at Visit 1 and Visit 3) and/or Fasting TGs ≥500 mg/dL (5.65 mmol/L, at Visit 1 and Visit 3)
• Patients should be receiving optimized stable therapy

You may not qualify if…

• Previous treatment with metreleptin
• Leptin levels >20.0 ng/mL
• Acquired or radiation induced partial lipodystrophy (APL)
• Other protocol defined inclusion/exclusion criteria apply

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• UC Davis — Sacramento, California, United States
• Flourish Boca Raton — Boca Raton, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Missouri — Columbia, Missouri, United States
• Amryt Research Site, Endocrinology Research Associates Inc — Columbus, Ohio, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• UZ Leuven — Leuven, Belgium
• Universitário Walter Cantídio — Fortaleza, Brazil
• Insight Centro de Pesquisas — Porto Alegre, Brazil
• Hospital das Clinicas FMRP-USP — Ribeirão Preto, Brazil
• Instituto Estadual de Diabetes e Endocrinologia (IEDE-RJ) — Rio de Janeiro, Brazil
• Nova Scotia Health — Halifax, Nova Scotia, Canada
• Care Access Clinic — Sydney, Nova Scotia, Canada
• Hamilton General Hospital- McMaster University — Hamilton, Ontario, Canada
• London Health Science Centre — London, Ontario, Canada
• Ecogene-21 — Chicoutimi, Quebec, Canada
• Faculty of Medicine, Universite Laval — Québec, Quebec, Canada
• Universidad Catolica — Santiago, Chile

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.