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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

December 17, 2021

Primary Completion Date

July 21, 2026

Study Completion Date

October 31, 2026

Conditions
Partial Lipodystrophy
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

Trial Locations (31)

19104

The Children's Hospital of Philadelphia, Philadelphia

30329

Emory University, Atlanta

33431

Flourish Boca Raton, Boca Raton

35233

University of Alabama, Birmingham

43201

Amryt Research Site, Endocrinology Research Associates Inc, Columbus

43210

The Ohio State University Wexner Medical Center, Columbus

48109

University of Michigan, Ann Arbor

53226

Medical College of Wisconsin, Milwaukee

55902

Mayo Clinic, Rochester

65212

University of Missouri, Columbia

75390

UT Southwestern Medical Center, Dallas

95817

UC Davis, Sacramento

02114

Massachusetts General Hospital, Boston

Unknown

UZ Leuven, Leuven

Universitário Walter Cantídio, Fortaleza

Insight Centro de Pesquisas, Porto Alegre

Hospital das Clinicas FMRP-USP, Ribeirão Preto

Instituto Estadual de Diabetes e Endocrinologia (IEDE-RJ), Rio de Janeiro

Universidad Catolica, Santiago

Hadassah University Hospital - Ein Kerem, Jerusalem

Leids Universitair Medisch Centrum, Leiden

Radboud University Medical Centre Interne Geneeskund, Nijmegen

Uniwersyteckie Centrum Kliniczne, Katowice

SPZOZ Szpital Uniwersytecki w Krakowie, Krakow

University Clinical Hospital of Santiago de Compostela/Hospital Universitario, Santiago de Compostela

B3H 2Y9

Nova Scotia Health, Halifax

B1M 0A1

Care Access Clinic, Sydney

L8N 3Z5

Hamilton General Hospital- McMaster University, Hamilton

N6A 5B7

London Health Science Centre, London

G7H 7K9

Ecogene-21, Chicoutimi

G1V4W2

Faculty of Medicine, Universite Laval, Québec

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amryt Pharma

INDUSTRY

NCT05164341 - Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL | Biotech Hunter | Biotech Hunter