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ACTIVE NOT RECRUITING
NCT05164341
PHASE3

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

Sponsor: Amryt Pharma

View on ClinicalTrials.gov

Summary

This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.

Official title: A 12-Month Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With Partial Lipodystrophy

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

69

Start Date

2021-12-17

Completion Date

2026-10-31

Last Updated

2025-08-29

Healthy Volunteers

No

Interventions

DRUG

metreleptin

Metreleptin is a recombinant human leptin analog that is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency

DRUG

Placebo

Placebo

Locations (31)

University of Alabama

Birmingham, Alabama, United States

UC Davis

Sacramento, California, United States

Flourish Boca Raton

Boca Raton, Florida, United States

Emory University

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Missouri

Columbia, Missouri, United States

Amryt Research Site, Endocrinology Research Associates Inc

Columbus, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

UZ Leuven

Leuven, Belgium

Universitário Walter Cantídio

Fortaleza, Brazil

Insight Centro de Pesquisas

Porto Alegre, Brazil

Hospital das Clinicas FMRP-USP

Ribeirão Preto, Brazil

Instituto Estadual de Diabetes e Endocrinologia (IEDE-RJ)

Rio de Janeiro, Brazil

Nova Scotia Health

Halifax, Nova Scotia, Canada

Care Access Clinic

Sydney, Nova Scotia, Canada

Hamilton General Hospital- McMaster University

Hamilton, Ontario, Canada

London Health Science Centre

London, Ontario, Canada

Ecogene-21

Chicoutimi, Quebec, Canada

Faculty of Medicine, Universite Laval

Québec, Quebec, Canada

Universidad Catolica

Santiago, Chile

Hadassah University Hospital - Ein Kerem

Jerusalem, Israel

Leids Universitair Medisch Centrum

Leiden, Netherlands

Radboud University Medical Centre Interne Geneeskund

Nijmegen, Netherlands

Uniwersyteckie Centrum Kliniczne

Katowice, Poland

SPZOZ Szpital Uniwersytecki w Krakowie

Krakow, Poland

University Clinical Hospital of Santiago de Compostela/Hospital Universitario

Santiago de Compostela, Spain