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
Amryt Pharma
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
Eligibility
- Age range
- 13+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥13 years of age, inclusive, at the time of signing the informed consent form (ICF). 2. Subjects must have completed the Parent study APG-20 and, in the opinion of the Investigator and Sponsor, have been compliant with study procedures through Parent study Month 12 visit. 3. Negative pregnancy test (urine or serum) for female subjects of childbearing potential 4. Female subjects must be postmenopausal (defined as cessation of menses for at least 1 year), surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation), or willing to use a highly effectiv…