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

a study on Lipodystrophy

Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

Summary

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

Official Title

A 12-Month Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With Partial Lipodystrophy

Keywords

Partial Lipodystrophy, metreleptin, Lipodystrophy

Eligibility

You can join if…

Open to people ages 12 years and up

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

You CAN'T join if...

  • Previous treatment with metreleptin
  • Leptin levels >20.0 ng/mL
  • Acquired or radiation induced partial lipodystrophy (APL)

Other protocol defined inclusion/exclusion criteria apply

Locations

  • UC Davis accepting new patients
    Sacramento California 95817 United States
  • UT Southwestern Medical Center accepting new patients
    Dallas Texas 75390 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amryt Pharma
ID
NCT05164341
Phase
Phase 3 Lipodystrophy Research Study
Study Type
Interventional
Participants
Expecting 65 study participants
Last Updated