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

Partial Lipodystrophy Clinical Trial

— METRE-PL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05164341
• Other study ID #: APG-20
• Status: Recruiting
• Phase: Phase 3
• Start date: December 17, 2021
• Est. completion date: January 31, 2026

Study information

• Verified date: March 2024
• Source: Amryt Pharma
• Contact: Janet Boylan
• Phone: +35315180200
• Email: medinfo[@]amrytpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: January 31, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Familial Partial Lipodystrophy (FPLD)

Exclusion Criteria:

• Previous treatment with metreleptin

Other protocol defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Lipodystrophy
• Partial Lipodystrophy

Intervention

Drug:
• metreleptin
Metreleptin is a recombinant human leptin analog that is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	Amryt Research Site, ECOGENE-21	Chicoutimi	Quebec
Canada	Amryt Research Site, Nova Scotia Health	Halifax	Nova Scotia
Canada	Amryt Research Site, Hamilton General Hospital- McMaster University	Hamilton	Ontario
Canada	Amryt Research Site, London Health Science Centre	London	Ontario
Canada	Amryt Research Site, Faculty of Medicine, Universite Laval	Québec	Quebec
United States	Amryt Research Site, University of Michigan	Ann Arbor	Michigan
United States	Amryt Research Site, University of Alabama	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Amryt Research Site, University of Missouri	Columbia	Missouri
United States	Amryt Research Site, Endocrinology Research Associates Inc	Columbus	Ohio
United States	Amryt Research Site, The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Amryt Research Site, UT Southwestern Medical Center	Dallas	Texas
United States	Amryt Research Site, Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Amryt Research Site, University of Pennsylvania	Philadelphia	Pennsylvania
United States	Amryt Research Site, Mayo Clinic,	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Amryt Pharma

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to month 6 in HbA1c in subjects with partial lipodystrophy (PL)	To evaluate the efficacy (HbAa1c) of daily SC metreleptin treatment	6 months
Primary	Percent change from Baseline to month 6 in fasting TGs in subjects with partial lipodystrophy (PL)	To evaluate the efficacy (TGs) of daily SC metreleptin treatment	6 months
Secondary	Safety analysis of AEs, AESIs, SAEs by treatment arm	To evaluate the safety of daily SC metreleptin treatment in subjects with PL	12 months
Secondary	Change from baseline to months 9 and 12 in HbA1c in subjects with partial lipodystrophy (PL)	To assess the effect of metreleptin on HbA1c	12 months
Secondary	Percent change from baseline to months 9 and 12 in fasting TGs in subjects with partial lipodystrophy (PL)	To assess the effect of metreleptin on TGs	12 months
Secondary	Change from Baseline to each assessment time point in quality of life (QoL) in all subjects	To assess the effect of metreleptin on quality of life (QoL) in all subjects	12 months