Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy

Condition(s) studied

Investigational drug(s) / intervention(s)

Metreleptin: Metreleptin is a recombinant human leptin analog that is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency

Study summary

This is an Open Label, Phase IV, Post Authorisation Study to Evaluate the Efficacy, Safety and Immunogenicity of Daily Subcutaneous Metreleptin Treatment in people with Partial Lipodystrophy

Eligibility

Primary outcome measure(s)

• Number of patients with decrease of at least 0.5% in glycated haemoglobin (HbA1c) at Month 12 compared to Baseline or HbA1c <6.5 % at Month 12, in patients with baseline HbA1c ≥6.5%. — 12 months
  To evaluate the efficacy (HbA1c) of metreleptin treatment in patients with PL
• Number of patients with decrease of at least 30% in triglycerides (TG) at Month 12 compared to Baseline, in patients with baseline TG levels ≥500 mg/dL (5.65 mmol/L) — 12 months
  To evaluate the efficacy (TG) of metreleptin treatment in patients with PL

Trial sites (12)

Other trials for the same condition