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

Description

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

Conditions

Partial Lipodystrophy
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Partial Lipodystrophy

Study Overview

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Study Details

Study overview

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

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

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

Condition
Partial Lipodystrophy
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama, Birmingham, Alabama, United States, 35233

Sacramento

UC Davis, Sacramento, California, United States, 95817

Boca Raton

Flourish Boca Raton, Boca Raton, Florida, United States, 33431

Atlanta

Emory University, Atlanta, Georgia, United States, 30329

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55902

Columbia

University of Missouri, Columbia, Missouri, United States, 65212

Columbus

Amryt Research Site, Endocrinology Research Associates Inc, Columbus, Ohio, United States, 43201

Columbus

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of Familial Partial Lipodystrophy (FPLD)
  • * Subjects with poor metabolic control defined as:
  • * Patients should be receiving optimized stable therapy
  • * Previous treatment with metreleptin
  • * Leptin levels \>20.0 ng/mL
  • * Acquired or radiation induced partial lipodystrophy (APL)

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amryt Pharma,

Study Record Dates

2026-10-31