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

Recruiting
12 years of age
Both
Phase 3
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Overview

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

Eligibility

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 details

Partial Lipodystrophy

NCT05164341

Amryt Pharma

18 April 2025

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