Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL
NCT ID: NCT05164341
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
69 participants
INTERVENTIONAL
2021-12-17
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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metreleptin
Metreleptin \[Recombinant-methionyl human Leptin; r-metHuLeptin\] for daily injection is a sterile, white, solid lyophilised cake
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
placebo
Placebo for daily injection is a sterile, white, solid lyophilised cake
Placebo
Placebo
Interventions
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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
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Leptin levels \>20.0 ng/mL
* Acquired or radiation induced partial lipodystrophy (APL)
12 Years
ALL
No
Sponsors
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Amryt Pharma
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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APG-20
Identifier Type: -
Identifier Source: org_study_id
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