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NCT Number: NCT02325674

MEASuRE: Metreleptin Effectiveness And Safety Registry

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.

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Key information

Conditions

Generalised Lipodystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipodystrophy Lipodystrophy, Congenital Generalized Lipodystrophy, Partial, Acquired Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Partial Lipodystrophy Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Hôpital Claude Huriez, Lille, Nord, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metreleptin

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Lori Hartnett

CONTACT

[email protected]

+3905212791

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Acronym: MEASuRE

Important dates

Study start
2016
Primary completion
2031
Study completion
2031
First posted
Dec 25, 2014
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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