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

Partial Lipodystrophy

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

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    12 and up

Participation Criteria

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 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 Location

Nova Scotia Health
Nova Scotia Health
Halifax, Nova Scotia
Canada

Contact Study Team

Primary Contact

Thomas Ransom

[email protected]
902-473-7803
Faculty of Medicine, Universite Laval
Faculty of Medicine, Universite Laval
Québec, Quebec
Canada

Contact Study Team

Primary Contact

Stanley Weisnagel

Ecogene-21
Ecogene-21
Chicoutimi, Quebec
Canada

Contact Study Team

Primary Contact

Daniel Gaudet

Hamilton General Hospital- McMaster University
Hamilton General Hospital- McMaster University
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Marie Eva Pigeyre

[email protected]
905-297-3479
London Health Science Centre
London Health Science Centre
London, Ontario
Canada

Contact Study Team

Primary Contact

Robert Hegele

[email protected]
5199315271
Study Sponsored By
Amryt Pharma
Participants Required
More Information
Study ID: NCT05164341