MEASuRE: Metreleptin Effectiveness And Safety Registry

NCT02325674 · tracked via the Priya Life Science UK tracker

Sponsor

Chiesi Farmaceutici S.p.A.

Phase

Observational

Started

2016-10-11

Last updated

2026-07-16

Condition(s) studied

Generalised LipodystrophyPartial Lipodystrophy

Investigational drug(s) / intervention(s)

Metreleptin

Study summary

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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients treated with metreleptin through commercial supply at the time or before enrolment into registry * Patients who provide a written consent * Patient coming off metreleptin clinical studies and continuing or restarting treatment with metreleptin through commercial supply Exclusion Criteria: • Patients currently treated with an investigational agent as part of a clinical trial

Primary outcome measure(s)

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

Trial sites (28)

Facility	City	Region	Status
University Alabama at Birmingham	Birmingham	Alabama	Terminated
City of Hope	Duarte	California	Terminated
Atlanta Diabetes Associates	Atlanta	Georgia	Completed
Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	Recruiting
University of Kansas Medical Center Research Institute, Inc.	Kansas City	Kansas	Recruiting
Children's Hospital of New Orleans/LSU Health Sciences Center	New Orleans	Louisiana	Completed
Ochsner Clinic Foundation	New Orleans	Louisiana	Withdrawn
Nih/Niddk/Deob	Bethesda	Maryland	Recruiting
University of Michigan	Ann Arbor	Michigan	Recruiting
Childrens Hospital of Michigan	Detroit	Michigan	Recruiting
Richmond University Medical Centre	Staten Island	New York	Completed
Endocrinology Research Associates	Columbus	Ohio	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	Recruiting
University of Pennsylvania	Philadelphia	Pennsylvania	Withdrawn
UT Southwestern Medical Center	Dallas	Texas	Recruiting
Seattle Children's Hospital	Seattle	Washington	Recruiting
CHRU Hôpital Claude Huriez	Lille	Nord	Recruiting
Hôpital Robert Debré	Paris	Paris, France	Recruiting
Hôpital Saint-Antoine	Paris	Paris	Recruiting
Universitaetsklinikum Ulm	Ulm	Baden-Wurttemberg	Recruiting
Kinderkrankenhaus Auf der Bult	Hanover	Lower Saxony	Recruiting
Universitaetsklinikum Muenster	Münster	North Rhine-Westphalia	Recruiting
Universitaetsklinikum Leipzig AoeR	Leipzig	Saxony	Recruiting
Alma Mater Studiorum - Università di Bologna	Bologna	Bologna	Recruiting
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)	Pisa	Pisa	Recruiting
Azienda Ospedaliera Universitaria Policlinico Tor Vergata	Roma	Roma	Withdrawn
Universita del Piemonte Orientale "Amedeo Avogadro"	Novara	Verceilli	Recruiting
Addenbrooke's Hospital	Cambridge	Cambridge	Recruiting

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Other trials for the same condition

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02325674 on ClinicalTrials.gov ↗ ← All trials in the UK