ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-12-17
Study Completion:2026-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05164341

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.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of Familial Partial Lipodystrophy (FPLD)
  2. * Subjects with poor metabolic control defined as:
  3. * Patients should be receiving optimized stable therapy
  1. * Previous treatment with metreleptin
  2. * Leptin levels \>20.0 ng/mL
  3. * Acquired or radiation induced partial lipodystrophy (APL)

Contacts and Locations

Study Locations (Sites)

University of Alabama
Birmingham, Alabama, 35233
United States
UC Davis
Sacramento, California, 95817
United States
Flourish Boca Raton
Boca Raton, Florida, 33431
United States
Emory University
Atlanta, Georgia, 30329
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Mayo Clinic
Rochester, Minnesota, 55902
United States
University of Missouri
Columbia, Missouri, 65212
United States
Amryt Research Site, Endocrinology Research Associates Inc
Columbus, Ohio, 43201
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Amryt Pharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-17
Study Completion Date2026-10-31

Study Record Updates

Study Start Date2021-12-17
Study Completion Date2026-10-31

Terms related to this study

Keywords Provided by Researchers

  • metreleptin

Additional Relevant MeSH Terms

  • Partial Lipodystrophy