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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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
University of Alabama
Birmingham, Alabama, United States
RECRUITINGFlourish Research
Boca Raton, Florida, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
Evaluate the Incidence and Frequency of Treatment-Emergent Adverse Events (Safety and Tolerability)
Incidence and frequency of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), treatment-related TEAEs, adverse events of special interest (AESI), and adverse events leading to study treatment discontinuation/withdrawal from the study
Time frame: From enrollment to the end of treatment (until the last participant completes 24 months)
To evaluate the long-term efficacy (HbA1c) of daily SC metreleptin treatment in participants with familial partial lipodystrophy (FPLD)
Glycated hemoglobin (HbA1c) in participants with HbA1c ≥7% at the Parent study Baseline, over time during the OLE
Time frame: From enrollment to the end of treatment (until the last participant completes 24 months)
To evaluate the long-term efficacy (TGs) of daily SC metreleptin treatment in participants with FPLD
\- Fasting triglycerides (TGs) in participants with TG ≥500 mg/dL at the Parent study Baseline, over time during the OLE
Time frame: From enrollment to the end of treatment (until the last participant completes 24 months)
To evaluate the long-term efficacy (FBG) of daily SC metreleptin treatment in participants with FPLD
* Fasting blood glucose (FBG) in participants with HbA1c ≥7% at the Parent study Baseline, over time during the OLE * FBG in participants with FBG above upper limit of normal (ULN) at the Parent study Baseline, over time during the OLE
Time frame: From enrollment to the end of treatment (until the last participant completes 24 months)
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University of Michigan
Ann Arbour, Michigan, United States
RECRUITINGChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGUT Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGThe Medical College of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITING