Last updated 26 days ago

Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL

65 patients around the world

Available in Brazil, United States, Chile

Amryt Pharma

4Research sites

65Patients around the world

This study is for people with

Syndromes with Skin Anomalies

Familial Partial Lipodystrophy

From 12 Years

All Gender

: Diagnosis of Familial Partial Lipodystrophy (FPLD).
Subjects with poor metabolic control defined as: HbA1c ≥7% (at Visit 1 and Visit 3) and/or Fasting TGs ≥500 mg/dL (5.65 mmol/L, at Visit 1 and Visit 3).
Patients should be receiving optimized stable therapy.
Other protocol defined inclusion/exclusion criteria apply.

: Previous treatment with metreleptin.
Leptin levels >20.0 ng/mL.
Acquired or radiation induced partial lipodystrophy (APL).

Hospital Universitário Walter Cantídio - Universidade Federal do Ceará - Fortaleza, Ceara

Recruiting

Rua Coronel Nunes de Melo, S/N, Unidade de Pesquisa Clínica - 1º andar, Fortaleza, Ceara

Insight Centro de Pesquisas

Recruiting

Av. Cristóvão Colombo - Floresta, Porto Alegre - RS, 90560-003

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Recruiting

Campus Universitário S/N, Bloco G Subsolo II, Monte Alegre, Ribeirão Preto, Sao Paulo

Hospital Clínico Pontificia Universidad Católica de Chile - Santiago, Región Metropolitana

Recruiting

Portugal 61, Santiago

StudyMETRE-PL

SponsorAmryt Pharma

Study typeInterventional

Conditions

Familial Partial Lipodystrophy

Requirements

From 12 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05164341