Skip to main content
ENDO 2026 Main banner

Adipose Tissue_Appetite_and Obesity

SUN-676 - A 12-Month Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Safety and Efficacy of Metreleptin in Subjects with Partial Lipodystrophy: The METRE-PL Study

Sunday, June 14, 2026
9:00 AM - 4:00 PM CT
Location: ENDOExpo; Poster Floor

    Senior Author/Primary Investigator(s)

  • LF

    Lindsay T. Fourman, MD

    Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA
    Boston, Massachusetts, United States

    • Co-Author(s)

  • LF

    Lindsay T. Fourman, MD

    Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA
    Boston, Massachusetts, United States

    • Senior Author/Primary Investigator(s)

  • RM

    Renan M. Montenegro, Jr., MD, PhD (he/him/his)

    Professor of Endocrinology, Metabolism and Diabetes
    Faculty of Medicine, Federal University of Ceara, Brazil
    Fortaleza, Ceara, Brazil

    • Co-Author(s)

  • RM

    Renan M. Montenegro, Jr., MD, PhD (he/him/his)

    Professor of Endocrinology, Metabolism and Diabetes
    Faculty of Medicine, Federal University of Ceara, Brazil
    Fortaleza, Ceara, Brazil

    • Senior Author/Primary Investigator(s)

  • MM

    Maciej Małecki, MD

    Jagiellonian University Medical College, Kraków, Poland
    Kraków, Poland

    • Co-Author(s)

  • MM

    Maciej Małecki, MD

    Jagiellonian University Medical College, Kraków, Poland
    Kraków, Poland

    • Senior Author/Primary Investigator(s)

  • CV

    Cynthia Valerio, MD

    Institute of Diabetes and Endocrinology of Rio de Janeiro, Rio de Janeiro, Brazil
    Rio de Janeiro, Brazil

    • Co-Author(s)

  • CV

    Cynthia Valerio, MD

    Institute of Diabetes and Endocrinology of Rio de Janeiro, Rio de Janeiro, Brazil
    Rio de Janeiro, Brazil

    • Senior Author/Primary Investigator(s)

  • SW

    S John Weisnagel, MD

    Endocrinologist
    Université Laval, Québec, Canada
    Québec, Quebec, Canada

    • Co-Author(s)

  • SW

    S John Weisnagel, MD

    Endocrinologist
    Université Laval, Québec, Canada
    Québec, Quebec, Canada

    • Senior Author/Primary Investigator(s)

  • Fd

    Francisco Jose Albuquerque de Paula, MD, PhD

    Ribeirao Preto Medical School, University of Sao Paulo, Ribeirão Preto, Sao Paulo, Brazil
    Ribeirão Preto, Sao Paulo, Brazil

    • Co-Author(s)

  • Fd

    Francisco Jose Albuquerque de Paula, MD, PhD

    Ribeirao Preto Medical School, University of Sao Paulo, Ribeirão Preto, Sao Paulo, Brazil
    Ribeirão Preto, Sao Paulo, Brazil

    • Senior Author/Primary Investigator(s)

  • JR

    Joost H. Rutten, MD, PhD

    Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
    Nijmegen, Netherlands

    • Co-Author(s)

  • JR

    Joost H. Rutten, MD, PhD

    Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
    Nijmegen, Netherlands

    • Senior Author/Primary Investigator(s)

  • RD

    Ronen Durst, MD

    Hadassah Hebrew University Medical Center, Jerusalem, Israel
    Jerusalem, Israel

    • Co-Author(s)

  • RD

    Ronen Durst, MD

    Hadassah Hebrew University Medical Center, Jerusalem, Israel
    Jerusalem, Israel

    • Senior Author/Primary Investigator(s)

  • RH

    Robert A. Hegele, MD (he/him/his)

    Professor
    University of Western Ontario, London, Ontario, Canada
    London, Ontario, Canada

    • Co-Author(s)

  • RH

    Robert A. Hegele, MD (he/him/his)

    Professor
    University of Western Ontario, London, Ontario, Canada
    London, Ontario, Canada

    • Senior Author/Primary Investigator(s)

  • Troy Puar, MBBS, FRCP, PhD

    Senior Consultant
    CGH
    Singapore, SINGAPORE

    • Co-Author(s)

  • Troy Puar, MBBS, FRCP, PhD

    Senior Consultant
    CGH
    Singapore, SINGAPORE

    • Senior Author/Primary Investigator(s)

  • VB

    Vaneeta Bamba, MD

    Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania, United States

    • Co-Author(s)

  • VB

    Vaneeta Bamba, MD

    Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania, United States

    • Senior Author/Primary Investigator(s)

  • CB

    Cassiane Cardoso Bonato, MD/PhD

    Principal Investigator
    Insight Centro de Pesquisas, Porto Alegre, Rio Grande do Sul, Brazil
    Porto Alegre, Rio Grande do Sul, Brazil

    • Co-Author(s)

  • CB

    Cassiane Cardoso Bonato, MD/PhD

    Principal Investigator
    Insight Centro de Pesquisas, Porto Alegre, Rio Grande do Sul, Brazil
    Porto Alegre, Rio Grande do Sul, Brazil

    • Senior Author/Primary Investigator(s)

  • Elena A. Christofides, MD (she/her/hers)

    CEO
    ENDOCRINOLOGY ASSOCIATES, INC
    Columbus, OH, United States

    • Co-Author(s)

  • Elena A. Christofides, MD (she/her/hers)

    CEO
    ENDOCRINOLOGY ASSOCIATES, INC
    Columbus, OH, United States

    • Senior Author/Primary Investigator(s)

  • Bradley Javorsky, MD

    Associate Professor of Medicine
    Medical College of Wisconsin
    Milwaukee, WI, United States

    • Co-Author(s)

  • Bradley Javorsky, MD

    Associate Professor of Medicine
    Medical College of Wisconsin
    Milwaukee, WI, United States

    • Senior Author/Primary Investigator(s)

  • AM

    Ann Mertens, MD

    UZ Leuven, Leuven, Belgium
    Leuven, Belgium

    • Co-Author(s)

  • AM

    Ann Mertens, MD

    UZ Leuven, Leuven, Belgium
    Leuven, Belgium

    • Senior Author/Primary Investigator(s)

  • FO

    Fernando Ovalle, MD

    Professor of Medicine & Division Director
    University of Alabama at Birmingham
    Birmingham, AL, United States

    • Co-Author(s)

  • FO

    Fernando Ovalle, MD

    Professor of Medicine & Division Director
    University of Alabama at Birmingham
    Birmingham, AL, United States

    • Senior Author/Primary Investigator(s)

  • MP

    Marie Pigeyre, MD

    McMaster University, Hamilton, Ontario, Canada
    Hamilton, Ontario, Canada

    • Co-Author(s)

  • MP

    Marie Pigeyre, MD

    McMaster University, Hamilton, Ontario, Canada
    Hamilton, Ontario, Canada

  • TR

    Thomas Ransom, MD, MSc

    Associate Professor of Medicine
    QEIIHSC/Dalhousie University, Halifax, Nova Scotia, Canada
    Halifax, Nova Scotia, Canada

  • KW

    Kathleen Wyne, MD

    The Ohio State University, Columbus, Ohio, USA
    Columbus, Ohio, United States

    • Senior Author/Primary Investigator(s)

  • RY

    Rasha Youssef, MD

    principal investigator
    Flourish Research, Boca Raton, Florida, USA
    Boca Raton, Florida, United States

    • Co-Author(s)

  • RY

    Rasha Youssef, MD

    principal investigator
    Flourish Research, Boca Raton, Florida, USA
    Boca Raton, Florida, United States

  • BA

    Baris Akinci, MD

    Izmir Biomedicine and Genome Center, Izmir, Turkey
    Izmir, Turkey

  • MB

    Miriam Barry, MSc

    Chiesi Global Rare Diseases, Dublin, Ireland
    Dublin, Dublin, Ireland

  • LB

    Liliana Batista, PhD

    Chiesi Global Rare Diseases, Parma, Italy
    Parma, Emilia-Romagna, Italy

  • OC

    Orla Casey, PhD

    Chiesi Global Rare Diseases, Dublin, Ireland
    Dublin, Ireland

  • SF

    Shir Fuchs Orenbach, MD MSc

    Chiesi Global Rare Diseases, Dublin, Ireland
    Dublin, Ireland

  • SP

    Shlomi Perltzweig, BSc, MBA

    Chiesi Global Rare Diseases, Dublin, Ireland
    Dublin, Dublin, Ireland

    • Senior Author/Primary Investigator(s)

  • AG

    Abhimanyu Garg, MD

    University of Texas Southwest Medical Center, Dallas, Texas, USA
    Dallas, Texas, United States

    • Co-Author(s)

  • AG

    Abhimanyu Garg, MD

    University of Texas Southwest Medical Center, Dallas, Texas, USA
    Dallas, Texas, United States

    • Abstract Poster Presenter(s)

  • Elif A. Oral, MD (she/her/hers)

    Professor
    University of Michigan
    Ann Arbor, MI, United States

    • Senior Author/Primary Investigator(s)

  • Elif A. Oral, MD (she/her/hers)

    Professor
    University of Michigan
    Ann Arbor, MI, United States

Disclosure(s):
Elena A. Christofides, MD: .NovoNordisk: Clinical Trial Investigator (); Abbott Diabetes Care: Advisory Board (), Speakers' Bureau (); Amgen: Clinical Trial Investigator (); Camurus: Consultant (); Chiesi Global Rare Diseases: Clinical Trial Investigator (); Eli Lilly & Company: Clinical Trial Investigator (), Speakers' Bureau (); Recordati Rare Disease: Consultant (), Speakers' Bureau (); Sparrow Therapeutics: Advisory Board (), Clinical Trial Investigator (), Consultant (); Xeris: Consultant (), Speakers' Bureau ()
Bradley Javorsky, MD: Chiesi Farmaceutici: Clinical Trial Investigator ()
Fernando Ovalle, MD: No relevant disclosure to display
Elif A. Oral, MD: No relevant disclosure to display
Background. Lipodystrophy syndromes are a group of rare disorders characterized by the generalized or partial lack of adipose tissue and are associated with multiple metabolic and organ system comorbidities. Metreleptin, a recombinant human leptin analog, is approved (with diet) in the United States to treat the metabolic complications of leptin deficiency in generalized lipodystrophy but not partial lipodystrophy (PL). Previous non-randomized, open-label clinical studies support the efficacy and safety of metreleptin in PL, especially in patients with severe metabolic disease. Here, we describe the eligibility criteria and baseline characteristics of patients included in METRE-PL (NCT05164341), a 12-month, randomized, multicenter, double-blind, placebo-controlled phase 3 study evaluating the efficacy and safety of metreleptin in patients with familial PL (FPLD, a genetic form of PL).
Methods. Patients aged ≥12 years with an established diagnosis of FPLD and metabolic abnormalities (HbA1c ≥ 7% and/or fasting triglycerides (TG) ≥ 500 mg/dL) despite optimized and stable medical treatment were eligible for inclusion. Key exclusion criteria included prior metreleptin treatment, leptin levels > 20 ng/ml, acquired PL, and HIV-associated lipodystrophy.
Results. Overall, 69 patients (90% female; mean age, 44.8 years) from 22 sites across 7 countries were randomized 1:1 to receive metreleptin (maximum dose, 10mg/day) or placebo. At baseline, 93% of patients had diabetes and 83% had hypertriglyceridemia. Pancreatitis (29%) and diabetic neuropathy (29%) were the most common end-organ complications. Mean (±SD; minimum-maximum) values for HbA1c and TG were 8.6 (±1.53; 4.9-12.9)% and 696 (±1001.1; 81-5487) mg/dL, respectively. The median leptin value was 8.3 ng/ml. Nearly all patients were taking ≥ 1 anti-diabetic therapy (96%) or ≥ 1 lipid lowering therapy (91%). Co-primary endpoints for the study are: (1) change in HbA1c from baseline to Month 6 in patients with pre-treatment HbA1c ≥ 7%, and (2) percentage change in TG from baseline to Month 6 in patients with pre-treatment TG ≥ 500 mg/dL. Safety is assessed throughout the study and at safety follow-up visits post-treatment.
Conclusion. METRE‑PL is the first placebo‑controlled clinical study to evaluate the therapeutic efficacy and safety of metreleptin in patients with FPLD. The baseline characteristics of the study population highlight the multi-systemic burden of disease and the need for effective management of the metabolic complications of FPLD. Trial results may support further therapeutic strategies for patients with this rare disease.

*Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*