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Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy | Clinical Trials | Clareo Health

RECRUITINGPHASE4

Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy

A 24-Month, Multi-Centre, Open Label Phase IV Post Authorisation Efficacy Study to Evaluate the Efficacy, Safety and Immunogenicity of Daily Subcutaneous Metreleptin Treatment in Patients With Partial Lipodystrophy

NCT06484868•Amryt Pharma

View on ClinicalTrials.gov

Summary

This is an Open Label, Phase IV, Post Authorisation Study to Evaluate the Efficacy, Safety and Immunogenicity of Daily Subcutaneous Metreleptin Treatment in people with Partial Lipodystrophy

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Confirmed diagnosis of familial or acquired partial lipodystrophy

Exclusion Criteria

•Treatment with any Investigational Medicinal Product (IMP) within 6 months or 5 times the terminal half-life of the corresponding IMP, whichever is longer, before the screening visit.

Locations (12)

Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

Lille, France

Hopital Pitie-Salpetriere

Paris, France

Hôpital Saint-Antoine

Paris, France

Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

Berlin, Germany

Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin

Ulm, Germany

Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

Bologna, Italy

Universitá degli Studi "Magna Graecia" di Catanzaro

Catanzaro, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

Novara, Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

Pisa, Italy

Key Dates

Start Date

February 8, 2024

Primary Completion Date

February 1, 2028

Completion Date

February 1, 2028

Last Updated

July 3, 2025

Enrollment

ESTIMATED participants

Conditions

Partial Lipodystrophy

Interventions

Metreleptin

DRUG

Contacts

Janet Boylan

CONTACT

+3905212791 clinicaltrials_info@chiesi.com

Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy

NCT06679270

Familial Partial Lipodystrophy

View study

TERMINATEDPHASE2/PHASE3

The BROADEN Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Partial Lipodystrophy

NCT02527343

Familial Partial Lipodystrophy

View study

COMPLETEDPHASE2

CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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