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

NCT ID: NCT06484868

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-08

Study Completion Date

2028-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Partial Lipodystrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metreleptin

Metreleptin \[Recombinant-methionyl human Leptin; r-metHuLeptin\] for daily injection is a sterile, white, solid lyophilised cake

Group Type EXPERIMENTAL

Metreleptin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Amryt Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Lille, , France

Site Status RECRUITING

Hopital Pitie-Salpetriere

Paris, , France

Site Status RECRUITING

Hôpital Saint-Antoine

Paris, , France

Site Status RECRUITING

Centre Hospitalier Lyon-Sud

Pierre-Bénite, , France

Site Status RECRUITING

Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

Berlin, , Germany

Site Status RECRUITING

Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin

Ulm, , Germany

Site Status NOT_YET_RECRUITING

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

Bologna, , Italy

Site Status RECRUITING

Universitá degli Studi "Magna Graecia" di Catanzaro

Catanzaro, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

Novara, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

Pisa, , Italy

Site Status RECRUITING

A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia

Udine, , Italy

Site Status RECRUITING

Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

Cambridge, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France Germany Italy United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Janet Boylan

Role: CONTACT

+3905212791

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marie-Christine Vantyghem

Role: primary

Fabrizio Andreelli

Role: primary

Corinne Vigouroux

Role: primary

Emmanuel Disse

Role: primary

Thomas Bobbert

Role: primary

Martin Wabitsch

Role: primary

Alessandra Gambineri

Role: primary

Antonio Aversa

Role: primary

Flavia Prodam

Role: primary

Giovanni Ceccarini

Role: primary

Annalisa Sechi

Role: primary

Anna Stears

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-502950-14-00

Identifier Type: CTIS

Identifier Source: secondary_id

APL-22

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.