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New treatment option for Generalized Lipodystrophy
Official title Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy
ClinicalTrials.gov ID: NCT06502990
What this study is testing
What is Metreleptin?
Metreleptin is an investigational medicine, being studied as a potential treatment for generalized lipodystrophy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, Phase 3b study to evaluate effectiveness, safety and pharmacokinetic parameters of metreleptin in patients under 6 years of age with generalised lipodystrophy and associated diabetes mellitus and/or hypertriglyceridaemia
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 5
You may be able to join if
- Confirmed diagnosis of Generalised Lipodystrophy
- Metreleptin treatment naive
You likely can't join if
- Weight \<9 kg at Screening (Visit 1)
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
- Paris, France
- Hamburg, Germany
- Ulm, Germany
- Chieti, Italy
- Naples, Italy
- Novara, Italy
- Parma, Italy
- Pisa, Italy
- Rome, Italy
- Varese, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 5 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium; Paris, France; Hamburg, Germany; Ulm, Germany; Chieti, Italy; Naples, Italy and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.