NCT06679270

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

An Open-label Extension of APG-20 Study to Evaluate the Long-term Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With Partial Lipodystrophy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Amryt Pharma · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

This Phase 3 study is an Open Label Extension of the APG-20 Study To Evaluate the Long-term Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects with Partial Lipodystrophy

Conditions

• Familial Partial Lipodystrophy

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2024-10-14
• Primary completion: 2028-03-01
• Completion: 2028-12-01
• First posted: 2024-11-07
• Last updated: 2026-02-02

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study