Health Trials

Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy

ConditionGeneralized Lipodystrophy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 5
SponsorAmryt Pharma

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

Eligibility criteria

Qualifiers

Confirmed diagnosis of Generalised Lipodystrophy

Metreleptin treatment naive

Disqualifiers

Weight <9 kg at Screening (Visit 1)

Trial design

Treatments tested in this trial

  • Metreleptin

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators

Amryt Pharma

Lead sponsor

Source ClinicalTrials.gov