Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy
Recruiting
Phase 3
Interventional Study
Generalized Lipodystrophy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- Up to 5
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 15 (estimated)
- Sponsor
- Amryt Pharma · Industry
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About This Trial
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
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Confirmed diagnosis of Generalised Lipodystrophy
* Metreleptin treatment naive
Exclusion Criteria:
* Weight \<9 kg at Screening (Visit 1)
Contacts