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Clinical Trials in Spain / NCT05164341
Active, not recruiting Phase 3

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

NCT05164341 · tracked via the Priya Life Science Spain tracker
Sponsor
Chiesi Farmaceutici S.p.A
Phase
Phase 3
Started
2021-12-17
Last updated
2026-06-15

Condition(s) studied

Partial Lipodystrophy

Investigational drug(s) / intervention(s)

metreleptin →Placebo

metreleptin: Metreleptin is a recombinant human leptin analog that is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency

Placebo: Placebo

Study summary

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

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 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

Primary outcome measure(s)

  • Change from baseline to month 6 in HbA1c in subjects with partial lipodystrophy (PL) — 6 months
    To evaluate the efficacy (HbAa1c) of daily SC metreleptin treatment
  • Percent change from Baseline to month 6 in fasting TGs in subjects with partial lipodystrophy (PL) — 6 months
    To evaluate the efficacy (TGs) of daily SC metreleptin treatment

Trial sites (31)

FacilityCityRegionStatus
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 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
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 Chile
Hadassah University Hospital - Ein Kerem Jerusalem Israel
Leids Universitair Medisch Centrum Leiden Netherlands
Radboud University Medical Centre Interne Geneeskund Nijmegen Netherlands
Uniwersyteckie Centrum Kliniczne Katowice Poland
SPZOZ Szpital Uniwersytecki w Krakowie Krakow Poland
University Clinical Hospital of Santiago de Compostela/Hospital Universitario Santiago de Compostela Spain

More Chiesi Farmaceutici S.p.A. trials in Spain

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Maternal and Postnatal Outcomes Study (MOS): A Global Observational Registry Assessing the Safety of Elfabrio® in Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding Recruiting
A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents With Fabry Disease Recruiting
A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05164341 on ClinicalTrials.gov ↗ ← All trials in Spain