This Phase 3, randomised, multicentre, double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of once-daily subcutaneous metreleptin in participants with partial lipodystrophy and associated metabolic complications. The study compares metreleptin with placebo over a 12-month treatment period, followed by an extension phase. The primary objective is to assess the effect of metreleptin on key metabolic parameters, including glycaemic control and hypertriglyceridemia.
Secondary objectives include evaluation of safety, tolerability, additional metabolic outcomes, liver-related parameters, and patient-reported outcomes in this rare disease population.
