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

Primary Purpose

Partial Lipodystrophy

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
metreleptin
Placebo
Sponsored by
Amryt Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Lipodystrophy focused on measuring metreleptin

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Familial Partial Lipodystrophy (FPLD)

Exclusion Criteria:

  • Previous treatment with metreleptin

Sites / Locations

  • Amryt Research Site, University of AlabamaRecruiting
  • Massachusetts General HospitalRecruiting
  • Amryt Research Site, University of MichiganRecruiting
  • Amryt Research Site, Mayo Clinic,Recruiting
  • Amryt Research Site, University of MissouriRecruiting
  • Amryt Research Site, Endocrinology Research Associates Inc
  • Amryt Research Site, The Ohio State University Wexner Medical CenterRecruiting
  • Amryt Research Site, University of PennsylvaniaRecruiting
  • Amryt Research Site, UT Southwestern Medical CenterRecruiting
  • Amryt Research Site, Medical College of WisconsinRecruiting
  • Amryt Research Site, Nova Scotia HealthRecruiting
  • Amryt Research Site, Hamilton General Hospital- McMaster UniversityRecruiting
  • Amryt Research Site, London Health Science CentreRecruiting
  • Amryt Research Site, ECOGENE-21Recruiting
  • Amryt Research Site, Faculty of Medicine, Universite LavalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

metreleptin

placebo

Arm Description

Metreleptin [Recombinant-methionyl human Leptin; r-metHuLeptin] for daily injection is a sterile, white, solid lyophilised cake

Placebo for daily injection is a sterile, white, solid lyophilised cake

Outcomes

Primary Outcome Measures

Change from baseline to month 6 in HbA1c in subjects with partial lipodystrophy (PL)
To evaluate the efficacy (HbAa1c) of daily SC metreleptin treatment
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

Secondary Outcome Measures

Safety analysis of AEs, AESIs, SAEs by treatment arm
To evaluate the safety of daily SC metreleptin treatment in subjects with PL
Change from baseline to months 9 and 12 in HbA1c in subjects with partial lipodystrophy (PL)
To assess the effect of metreleptin on HbA1c
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
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

Full Information

First Posted
November 11, 2021
Last Updated
September 25, 2023
Sponsor
Amryt Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT05164341
Brief Title
Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2021 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amryt Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Lipodystrophy
Keywords
metreleptin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
metreleptin
Arm Type
Active Comparator
Arm Description
Metreleptin [Recombinant-methionyl human Leptin; r-metHuLeptin] for daily injection is a sterile, white, solid lyophilised cake
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for daily injection is a sterile, white, solid lyophilised cake
Intervention Type
Drug
Intervention Name(s)
metreleptin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change from baseline to month 6 in HbA1c in subjects with partial lipodystrophy (PL)
Description
To evaluate the efficacy (HbAa1c) of daily SC metreleptin treatment
Time Frame
6 months
Title
Percent change from Baseline to month 6 in fasting TGs in subjects with partial lipodystrophy (PL)
Description
To evaluate the efficacy (TGs) of daily SC metreleptin treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety analysis of AEs, AESIs, SAEs by treatment arm
Description
To evaluate the safety of daily SC metreleptin treatment in subjects with PL
Time Frame
12 months
Title
Change from baseline to months 9 and 12 in HbA1c in subjects with partial lipodystrophy (PL)
Description
To assess the effect of metreleptin on HbA1c
Time Frame
12 months
Title
Percent change from baseline to months 9 and 12 in fasting TGs in subjects with partial lipodystrophy (PL)
Description
To assess the effect of metreleptin on TGs
Time Frame
12 months
Title
Change from Baseline to each assessment time point in quality of life (QoL) in all subjects
Description
To assess the effect of metreleptin on quality of life (QoL) in all subjects
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Familial Partial Lipodystrophy (FPLD) Exclusion Criteria: Previous treatment with metreleptin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janet Boylan
Phone
+35315180200
Email
medinfo@amrytpharma.com
Facility Information:
Facility Name
Amryt Research Site, University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Amryt Research Site, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Amryt Research Site, Mayo Clinic,
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Individual Site Status
Recruiting
Facility Name
Amryt Research Site, University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Name
Amryt Research Site, Endocrinology Research Associates Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Individual Site Status
Suspended
Facility Name
Amryt Research Site, The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Amryt Research Site, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Amryt Research Site, UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Amryt Research Site, Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Amryt Research Site, Nova Scotia Health
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Amryt Research Site, Hamilton General Hospital- McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Amryt Research Site, London Health Science Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5B7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Amryt Research Site, ECOGENE-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Amryt Research Site, Faculty of Medicine, Universite Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V4W2
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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