MEASuRE: Metreleptin Effectiveness And Safety Registry

The severity and incidence of the following safety events in patients prescribed Metreleptin in routine clinical practice

Time frame · Adverse events will be collected from first dose to last visit - min. 10 years. For Prevalent Users: Serious adverse events will be collected from 6 months prior to enrolment to last visit - min. 10 years.

Estimation of the incidence rates of the following events of special interest in patients treated with metreleptin as part of current clinical practice: acute pancreatitis associated with discontinuation of metreleptin including fatal or necrotizing pancreatitis, hepatic adverse events, severe hypoglycemia, serious hypersensitivity reactions, serious and severe infections resulting in hospitalization or death, loss of efficacy, new diagnoses of autoimmune disorders, autoimmune disease exacerbation, all cancers, exposed pregnancies and pregnancy outcomes, all-cause deaths, medication errors.

Characteristics of the study population in terms of demographic profile, vital signs and clinical signs

Time frame · Demographics and Vital Signs information will be collected at all study visits - min. 10 years

Description of the overall demographic and clinical characteristics in all patients treated with metreleptin (pattern of use analysis)

Characteristics of the study population in terms of clinical chemistry - Glycated Hemoglobin (HbA1c), Fasting Plasma Glucose (FPG) and Triglycerides (TG)

Time frame · Clinical chemistry will be collected at all study visits - min. 10 years

Description of routine laboratory measurements that could be inferred as efficacy endpoints (including HbA1c, FPG, and TG) over time

Characteristics of the study population in terms of its use of metreleptin

Time frame · Treatment information will be collected at all study visits - min. 10 years

Description of the metreleptin exposure information in all patients treated with metreleptin (pattern of use analysis)