An observational study in Generalised Lipodystrophy and Partial Lipodystrophy, sponsored by Chiesi Farmaceutici S.p.A.. Recruiting at 28 sites in 5 countries. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Chiesi Farmaceutici S.p.A. · Observational
The study is a post-authorization, prospective, voluntary registry of patients treated with commercial metreleptin including, but not limited to, patients in the US and EEA.
This is a non-interventional, multicentre, prospective, observational study of patients receiving treatment with commercial metreleptin for lipodystrophy in the US (GL) and EEA (GL and PL).
This registry will add to the knowledge about metreleptin gained from clinical trials by providing information on the incidence rates of acute pancreatitis associated with the discontinuation of metreleptin; and all cases of fatal or necrotizing pancreatitis, hepatic adverse events, hypoglycemia, hypersensitivity reactions, serious and severe infections, including serious infections resulting in hospitalization and death, loss of efficacy, new diagnoses of autoimmune disorders, exacerbation of existing autoimmune disorders, all cancers (excluding non-melanoma skin cancer) by cancer type, exposed pregnancies, and all-cause deaths, in patients treated with metreleptin in routine clinical practice.
139 studies on the registry are indexed under Lipodystrophy; 10 are open to participants now.
This study's planned enrollment of 100 is close to the median of 104 across 34 observational studies indexed under Lipodystrophy.
Browse Lipodystrophy studies →Chiesi Farmaceutici S.p.A. is the lead sponsor of 185 studies on the registry; 22 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 11 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients in the US with Generalised Lipodystrophy treated with commercial Metreleptin, and patients in the EEA with either Generalised Lipodystrophy or Partial Lipodystrophy, treated with commercial Metreleptin
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metreleptin new-users Metreleptin prevalent users
Drug: Metreleptin
The severity and incidence of the following safety events in patients prescribed Metreleptin in routine clinical practice
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.
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.
Characteristics of the study population in terms of demographic profile, vital signs and clinical signs
Description of the overall demographic and clinical characteristics in all patients treated with metreleptin (pattern of use analysis)
Time frame: Demographics and Vital Signs information will be collected at all study visits - min. 10 years
Characteristics of the study population in terms of clinical chemistry - Glycated Hemoglobin (HbA1c), Fasting Plasma Glucose (FPG) and Triglycerides (TG)
Description of routine laboratory measurements that could be inferred as efficacy endpoints (including HbA1c, FPG, and TG) over time
Time frame: Clinical chemistry will be collected at all study visits - min. 10 years
Characteristics of the study population in terms of its use of metreleptin
Description of the metreleptin exposure information in all patients treated with metreleptin (pattern of use analysis)
Time frame: Treatment information will be collected at all study visits - min. 10 years
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