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RecruitingPHASE4INTERVENTIONAL

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

This study is exploring a medicine called metreleptin for individuals living with partial lipodystrophy. Partial lipodystrophy is a condition where the body loses fat in certain areas. This is a special type of study called an 'open-label, Phase IV' trial, which means it's happening after the medicine has already been approved. Everyone involved will know they are receiving metreleptin. Researchers want to understand more about how effective metreleptin is in treating partial lipodystrophy, if it has any side effects, and how the body's immune system responds to it. The goal is to gather more information to help people with this condition.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Amryt Pharma
Enrolment target
12
Start
08 Feb 2024
Estimated completion
01 Feb 2028

What is this study about?

This study is about a medicine called metreleptin, which is being investigated for people who have a condition called partial lipodystrophy. Partial lipodystrophy causes the body to lose fat in some areas, while sometimes building it up in others. This can lead to health problems.

The main aim of this study is to learn more about how well metreleptin works for people with partial lipodystrophy, if it's safe to use, and how the body reacts to it over time. This is a 'Phase IV' study, which means metreleptin has already been approved, and doctors are now gathering more real-world information about its use. Because it's 'open-label,' everyone involved in the study – patients and doctors – will know that metreleptin is the treatment being given.

By taking part, you could contribute to a better understanding of partial lipodystrophy and how metreleptin can help manage the condition. The information gathered from this study could improve care for many people living with this rare condition in the future.

Key takeaways

  • This study is for people with partial lipodystrophy.
  • It's looking at a medicine called metreleptin.
  • The study aims to understand how well metreleptin works and if it's safe.
  • Participants will know they are receiving metreleptin (it's 'open-label').
  • It's a post-approval study, gathering more real-world information.

Who may be eligible?

To join this study, you must have a clear diagnosis of partial lipodystrophy, whether it's a type you were born with (familial) or one you developed later (acquired).

There are also some reasons you might not be able to join. For example, if you've recently taken part in another medical study where you received an experimental (investigational) medicine, you would likely need to wait a certain amount of time before you could participate in this one. This waiting period is usually at least six months, or longer depending on the specific experimental medicine you used.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do I have a confirmed diagnosis of partial lipodystrophy (familial or acquired)?
  2. Have I taken part in another medical study using an experimental medicine in the last 6 months?
  3. Am I at least 12 years old?
  4. Am I comfortable injecting medicine under my skin (if applicable)?
Answer every question to see your result.

What does participation involve?

The information provided does not detail specific requirements for participation like number of visits, assessments, medication schedule, or total duration. However, generally in such studies, you would expect to have regular visits to the clinic for health checks, blood tests, and to discuss any changes in your health. You would receive the study medication (metreleptin) regularly, likely as an injection under the skin. The doctors and nurses would monitor your health closely, track how you're feeling, and check for any side effects. You would also have follow-up appointments after you finish the main treatment period.

Potential risks and benefits

Potential benefits of joining this study could include receiving a medicine that might help manage your partial lipodystrophy. You would also receive close medical attention and contribute to scientific knowledge. However, as with any medicine, metreleptin can have side effects, and its effectiveness might vary from person to person. There could also be discomfort from injections or blood tests. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
    Verified postcode
    Lille, France· Recruiting
  • Hopital Pitie-Salpetriere
    Verified postcode
    Paris, France· Recruiting
  • Hôpital Saint-Antoine
    Verified postcode
    Paris, France· Recruiting
  • Centre Hospitalier Lyon-Sud
    Verified postcode
    Pierre-Bénite, France· Recruiting
  • Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
    Verified postcode
    Berlin, Germany· Recruiting
  • Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin
    Verified postcode
    Ulm, Germany· Not yet recruiting
  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
    Verified postcode
    Bologna, Italy· Recruiting
  • Universitá degli Studi "Magna Graecia" di Catanzaro
    Verified postcode
    Catanzaro, Italy· Not yet recruiting
  • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
    Verified postcode
    Novara, Italy· Recruiting
  • Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello
    Verified postcode
    Pisa, Italy· Recruiting
  • A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia
    Verified postcode
    Udine, Italy· Recruiting
  • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
    Verified postcode
    Cambridge, United Kingdom· Not yet recruiting

Common questions

What is partial lipodystrophy?

Partial lipodystrophy is a condition where your body loses fat in certain parts of your body, and sometimes gains it in others.

What is metreleptin?

Metreleptin is a medicine being studied for its use in people with partial lipodystrophy.

What does 'open-label' mean?

It means everyone involved in the study, including you and your doctor, will know you are receiving metreleptin.

What does 'Phase IV study' mean?

It means the medicine has already been approved, and researchers are gathering more information about its effects in a real-world setting.

Can I stop participating in the study if I change my mind?

Yes, you can choose to leave the study at any point, and it won't affect your regular medical care.

How to find out more

Janet Boylan

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Open-label Study to Evaluate Metreleptin in Patients With Pa…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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