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

Last updated: April 1, 2025
Sponsor: Amryt Pharma
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Placebo

metreleptin

Clinical Study ID

NCT05164341
APG-20
  • Ages > 12
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • Previous treatment with metreleptin

  • Leptin levels >20.0 ng/mL

  • Acquired or radiation induced partial lipodystrophy (APL)

Other protocol defined inclusion/exclusion criteria apply

Study Design

Total Participants: 65
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 17, 2021
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Amryt Research Site

    Leuven,
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • Amryt Research Site

    Fortaleza,
    Brazil

    Active - Recruiting

  • Universitário Walter Cantídio

    Fortaleza,
    Brazil

    Active - Recruiting

  • Amryt Research Site

    Porto Alegre,
    Brazil

    Active - Recruiting

  • Insight Centro de Pesquisas

    Porto Alegre,
    Brazil

    Active - Recruiting

  • Amryt Research Site

    Ribeirão Preto,
    Brazil

    Active - Recruiting

  • Hospital das Clinicas FMRP-USP

    Ribeirão Preto,
    Brazil

    Active - Recruiting

  • Amryt Research Site

    Rio De Janeiro,
    Brazil

    Active - Recruiting

  • Instituto Estadual de Diabetes e Endocrinologia (IEDE-RJ)

    Rio De Janeiro,
    Brazil

    Active - Recruiting

  • Amryt Research Site, Nova Scotia Health

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Active - Recruiting

  • Nova Scotia Health

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Active - Recruiting

  • Care Access Clinic

    Sydney, Nova Scotia B1M 0A1
    Canada

    Active - Recruiting

  • Amryt Research Site, Hamilton General Hospital- McMaster University

    Hamilton, Ontario L8N 3Z5
    Canada

    Active - Recruiting

  • Hamilton General Hospital- McMaster University

    Hamilton, Ontario L8N 3Z5
    Canada

    Active - Recruiting

  • Amryt Research Site, London Health Science Centre

    London, Ontario N6A 5B7
    Canada

    Active - Recruiting

  • London Health Science Centre

    London, Ontario N6A 5B7
    Canada

    Active - Recruiting

  • Amryt Research Site, ECOGENE-21

    Chicoutimi, Quebec G7H 7K9
    Canada

    Active - Recruiting

  • Ecogene-21

    Chicoutimi, Quebec G7H 7K9
    Canada

    Active - Recruiting

  • Amryt Research Site, Faculty of Medicine, Universite Laval

    Québec, Quebec G1V4W2
    Canada

    Active - Recruiting

  • Faculty of Medicine, Universite Laval

    Québec, Quebec G1V4W2
    Canada

    Active - Recruiting

  • Universidad Catolica

    Santiago,
    Chile

    Active - Recruiting

  • Hadassah University Hospital - Ein Kerem

    Jerusalem,
    Israel

    Active - Recruiting

  • Amryt Research Site

    Leiden,
    Netherlands

    Active - Recruiting

  • Leids Universitair Medisch Centrum

    Leiden,
    Netherlands

    Active - Recruiting

  • Amryt Research Site

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Radboud University Medical Centre Interne Geneeskund

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Amryt Research Site

    Katowice,
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Katowice,
    Poland

    Active - Recruiting

  • Amryt Research Site

    Kraków,
    Poland

    Active - Recruiting

  • SPZOZ Szpital Uniwersytecki w Krakowie

    Kraków,
    Poland

    Active - Recruiting

  • Amryt Research Site

    Santiago De Compostela,
    Spain

    Site Not Available

  • University Clinical Hospital of Santiago de Compostela/Hospital Universitario

    Santiago De Compostela,
    Spain

    Site Not Available

  • Amryt Research Site, University of Alabama

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • University of Alabama

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • UC Davis

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Flourish Boca Raton

    Boca Raton, Florida 33431
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Amryt Research Site, University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Amryt Research Site, Mayo Clinic,

    Rochester, Minnesota 55902
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55902
    United States

    Active - Recruiting

  • Amryt Research Site, University of Missouri

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • University of Missouri

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • Amryt Research Site, Endocrinology Research Associates Inc

    Columbus, Ohio 43201
    United States

    Suspended

  • Amryt Research Site, The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Amryt Research Site, University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Amryt Research Site, UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Amryt Research Site, MultiCare Health System Institute for Research and Innovation

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Amryt Research Site, Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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