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
Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL
Status
Active, not recruiting
Phase
Phase 3
Enrollment
69
Locations
31
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.
Interventions
Treatment arms and agents.
DRUG
Placebo
Placebo
Timeline
From registration to results.
First posted
Dec 20, 2021
Study start
Dec 17, 2021
Primary completion
Jul 21, 2026
Study completion
Oct 31, 2026
Results posted
Not reported
Registry updated
Jun 15, 2026
Outcomes
What the study measures.
Primary outcomes
Change from baseline to month 6 in HbA1c in subjects with partial lipodystrophy (PL)
Time frame · 6 months
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)
Time frame · 6 months
To evaluate the efficacy (TGs) of daily SC metreleptin treatment
Secondary outcomes
Safety analysis of AEs, AESIs, SAEs by treatment arm
Time frame · 12 months
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)
Time frame · 12 months
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)
Time frame · 12 months
To assess the effect of metreleptin on TGs
Change from Baseline to each assessment time point in quality of life (QoL) in all subjects
Time frame · 12 months
To assess the effect of metreleptin on quality of life (QoL) in all subjects
Eligibility
Who can take part.
- Minimum age
- 12 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of Familial Partial Lipodystrophy (FPLD) * Subjects with poor metabolic control defined as: 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 Exclusion Criteria: * Previous treatment with metreleptin * Leptin levels \>20.0 ng/mL * Acquired or radiation induced partial lipodystrophy (APL) Other protocol defined inclusion/exclusion criteria apply
Study locations
31 registered sites.
Belgium · Brazil · Canada · Chile · Israel · Netherlands · Poland · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.
University of Alabama
Birmingham, Alabama, United States
UC Davis
Sacramento, California, United States
Flourish Boca Raton
Boca Raton, Florida, United States
Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
Amryt Research Site, Endocrinology Research Associates Inc
Columbus, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
UZ Leuven
Leuven, Belgium
Universitário Walter Cantídio
Fortaleza, Brazil
Insight Centro de Pesquisas
Porto Alegre, Brazil
Hospital das Clinicas FMRP-USP
Ribeirão Preto, Brazil
Instituto Estadual de Diabetes e Endocrinologia (IEDE-RJ)
Rio de Janeiro, Brazil
Nova Scotia Health
Halifax, Nova Scotia, Canada
Care Access Clinic
Sydney, Nova Scotia, Canada
Hamilton General Hospital- McMaster University
Hamilton, Ontario, Canada
London Health Science Centre
London, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
Faculty of Medicine, Universite Laval
Québec, Quebec, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Metreleptin.
NCT IDStudyPhase / statusEnrollmentUpdated
Metreleptin in Anorexia Nervosa
Gabriella Milos · Anorexia Nervosa
Phase 2
Recruiting
50
2026-07
A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD)
Regeneron · Generalized Lipodystrophy
Phase 3
Completed
9
2026-07
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Diabetes · Lipodystrophy
Phase 2
Active, not recruiting
29
2026-07
Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy
Amryt Pharma · Generalized Lipodystrophy
Phase 3
Terminated
1
2026-07
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Lipodystrophy · Diabetes
Phase 3
Active, not recruiting
24
2026-07
MEASuRE: Metreleptin Effectiveness And Safety Registry
Chiesi Farmaceutici S.p.A. · Generalised Lipodystrophy · Partial Lipodystrophy
Not applicable
Recruiting
100
2026-07
Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
Chiesi Farmaceutici S.p.A. · Familial Partial Lipodystrophy
Phase 3
Recruiting
24
2026-07
Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Lipodystrophy
Not applicable
Recruiting
90
2026-06
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Put the record in context.
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