NCT02325674

MEASuRE: Metreleptin Effectiveness And Safety Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Amryt Pharma · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Generalised Lipodystrophy
• Partial Lipodystrophy

Interventions

Type	Name	Description
DRUG	Metreleptin

Timeline

• Start date: 2016-10-11
• Primary completion: 2031-10-31
• Completion: 2031-10-31
• First posted: 2014-12-25
• Last updated: 2026-01-20

Locations

28 sites across 5 countries: United States, France, Germany, Italy, United Kingdom

Regulatory

• FDA-regulated drug study