drugset / Trial / NCT06502990

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

NCT06502990

Phase 3 Recruiting 15 enrolled Amryt Pharma
NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2025-05-23
Primary completion
2026-09-30
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Metreleptin Protein / enzyme biologic Other