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New registry tracks Real-World safety of rare disease drug metreleptin

NCT ID NCT02325674

Disease control Sponsor: Chiesi Farmaceutici S.p.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This registry monitors the safety and effectiveness of metreleptin in up to 100 people with generalized or partial lipodystrophy who are already taking the drug in routine care. Researchers will track serious events like pancreatitis, liver problems, infections, and cancers. The goal is to better understand risks and benefits outside of clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
metreleptin
What this could lead to
If successful, this registry will provide real-world safety data on metreleptin, helping doctors better manage lipodystrophy and reduce risks like pancreatitis.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results depend on voluntary reporting and may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2016

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients in the US with Generalised Lipodystrophy treated with commercial Metreleptin, and patients in the EEA with either Generalised Lipodystrophy or Partial Lipodystrophy, treated with commercial Metreleptin

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients treated with metreleptin through commercial supply at the time or before enrolment into registry * Patients who provide a written consent * Patient coming off metreleptin clinical studies and continuing or restarting treatment with metreleptin through commercial supply Exclusion Criteria: • Patients currently treated with an investigational agent as part of a clinical trial

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Conditions

The condition(s) this trial relates to.

acquired partial lipodystrophy generalized lipodystrophy lipodystrophy Lipodystrophy, Congenital Generalized partial lipodystrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Generalised lipodystrophy Partial lipodystrophy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    20 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Addenbrooke's Hospital

    RECRUITING

    Cambridge, Cambridge, CB2 0QQ, United Kingdom

  • Alma Mater Studiorum - Università di Bologna

    RECRUITING

    Bologna, Bologna, 40126, Italy

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Atlanta Diabetes Associates

    COMPLETED

    Atlanta, Georgia, 30318, United States

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    WITHDRAWN

    Roma, Roma, 00133, Italy

  • Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

    RECRUITING

    Pisa, Pisa, 56124, Italy

  • CHRU Hôpital Claude Huriez

    RECRUITING

    Lille, Nord, 59800, France

  • Children's Hospital of New Orleans/LSU Health Sciences Center

    COMPLETED

    New Orleans, Louisiana, 70118, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Childrens Hospital of Michigan

    RECRUITING

    Detroit, Michigan, 48201, United States

  • City of Hope

    TERMINATED

    Duarte, California, 91010, United States

  • Endocrinology Research Associates

    RECRUITING

    Columbus, Ohio, 43201, United States

  • Hôpital Robert Debré

    RECRUITING

    Paris, Paris, France, 75019, France

  • Hôpital Saint-Antoine

    RECRUITING

    Paris, Paris, 75012, France

  • Kinderkrankenhaus Auf der Bult

    RECRUITING

    Hanover, Lower Saxony, 0000, Germany

  • Nih/Niddk/Deob

    RECRUITING

    Bethesda, Maryland, 20892, United States

  • Ochsner Clinic Foundation

    WITHDRAWN

    New Orleans, Louisiana, 70121, United States

  • Richmond University Medical Centre

    COMPLETED

    Staten Island, New York, 10314, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Universita del Piemonte Orientale "Amedeo Avogadro"

    RECRUITING

    Novara, Verceilli, 13100, Italy

  • Universitaetsklinikum Leipzig AoeR

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • Universitaetsklinikum Muenster

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • Universitaetsklinikum Ulm

    RECRUITING

    Ulm, Baden-Wurttemberg, 89075, Germany

  • University Alabama at Birmingham

    TERMINATED

    Birmingham, Alabama, 40506, United States

  • University of Kansas Medical Center Research Institute, Inc.

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    WITHDRAWN

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.