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

Amryt Pharma

Status and phase: Enrolling; Phase 4

Conditions: Partial Lipodystrophy

Treatments: Drug: Metreleptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06484868

2022-502950-14-00 (EU Trial (CTIS) Number)

APL-22

Details and patient eligibility

About

This is an Open Label, Phase IV, Post Authorisation Study to Evaluate the Efficacy, Safety and Immunogenicity of Daily Subcutaneous Metreleptin Treatment in people with Partial Lipodystrophy

Enrollment: 12 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of familial or acquired partial lipodystrophy

Exclusion criteria

• Treatment with any Investigational Medicinal Product (IMP) within 6 months or 5 times the terminal half-life of the corresponding IMP, whichever is longer, before the screening visit.

Other protocol defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Metreleptin

Experimental group

Description:

Metreleptin \[Recombinant-methionyl human Leptin; r-metHuLeptin\] for daily injection is a sterile, white, solid lyophilised cake

Treatment:

Drug: Metreleptin