Metreleptin

Generic Name: Metreleptin

Brand Names: Myalept, Myalepta

Drug Type: Biotech

Chemical Formula: -

CAS Number: 186018-45-1

Unique Ingredient Identifier: TL60C27RLH

Background: Metreleptin, a recombinant analog of the human hormone leptin, is an orphan drug used to treat complications of leptin deficiency in people with congenital or acquired lipodystrophy. Affecting less than 500 people worldwide, lipodystrophy is characterized by a lack of adipose tissue, fat deposition in the muscles and liver, and metabolic complications such a...

Indication: Metreleptin is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.

Associated Conditions: Congenital leptin deficiency

Associated Therapies: -

Clinical Trials

Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy

Phase 3

Recruiting

Conditions: Familial Partial Lipodystrophy

Interventions: Drug: Metreleptin

First Posted Date: 2024-11-07

Last Posted Date: 2024-12-17

Lead Sponsor: Amryt Pharma

Target Recruit Count: 15

Registration Number: NCT06679270

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
University of Michigan, Ann Arbor, Michigan, United States
🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States

and more 1 locations

Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy

Phase 3

Recruiting

Conditions: Generalized Lipodystrophy

Interventions: Drug: Metreleptin

First Posted Date: 2024-07-16

Last Posted Date: 2024-07-16

Lead Sponsor: Amryt Pharma

Target Recruit Count: 15

Registration Number: NCT06502990

Locations: 🇮🇹
Azienda Ospedaliera Universitaria "Federico II", Naples, Italy
🇫🇷
Hôpital Necker - Enfants Malades, Paris, France
🇩🇪
Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

and more 7 locations

Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy

Phase 4

Recruiting

Conditions: Partial Lipodystrophy

Interventions: Drug: Metreleptin

First Posted Date: 2024-07-03

Last Posted Date: 2024-07-03

Lead Sponsor: Amryt Pharma

Target Recruit Count: 12

Registration Number: NCT06484868

Locations: 🇮🇹
Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello, Pisa, Italy
🇫🇷
Hopital Pitie-Salpetriere, Paris, France
🇮🇹
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara, Novara, Italy

and more 9 locations

Metreleptin in Anorexia Nervosa

Phase 2

Not yet recruiting

Conditions: Anorexia Nervosa

Interventions: Drug: Metreleptin
Drug: Sodium chloride

First Posted Date: 2024-03-12

Last Posted Date: 2024-03-15

Lead Sponsor: Gabriella Milos

Target Recruit Count: 50

Registration Number: NCT06305182

Locations: 🇨🇭
Eating Disorder Unit, Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, Zurich, Switzerland

Evaluation of Safety and Efficiency of Metreleptin Treatment for Patients With Multiple Symmetric Lipomatosis (MSL)

Phase 2

Active, not recruiting

Conditions: Lipomatosis, Multiple Symmetrical

Interventions: Drug: Metreleptin

First Posted Date: 2022-04-28

Last Posted Date: 2024-04-19

Lead Sponsor: University of Michigan

Target Recruit Count: 4

Registration Number: NCT05351164

Locations: 🇺🇸
University of Michigan, Ann Arbor, Michigan, United States

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

Phase 3

Recruiting

Conditions: Partial Lipodystrophy

Interventions: Drug: metreleptin
Drug: Placebo

First Posted Date: 2021-12-20

Last Posted Date: 2024-12-12

Lead Sponsor: Amryt Pharma

Target Recruit Count: 65

Registration Number: NCT05164341

Locations: 🇺🇸
University of Alabama, Birmingham, Alabama, United States
🇺🇸
Flourish Boca Raton, Boca Raton, Florida, United States
🇺🇸
University of Michigan, Ann Arbor, Michigan, United States

and more 24 locations

The Effects of Metreleptin in Congenital Leptin Deficiency

Completed

Conditions: Congenital Leptin Deficiency (Disorder)

First Posted Date: 2019-08-21

Last Posted Date: 2021-12-30

Lead Sponsor: Northwestern University

Target Recruit Count: 2

Registration Number: NCT04063488

Locations: 🇺🇸
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy

Phase 4

Active, not recruiting

Conditions: Generalized Lipodystrophy

Interventions: Drug: Metreleptin

First Posted Date: 2019-07-19

Last Posted Date: 2024-03-12

Lead Sponsor: Aegerion Pharmaceuticals, Inc.

Target Recruit Count: 10

Registration Number: NCT04026178

Locations: 🇺🇸
Endocrinology Research Associates, Columbus, Ohio, United States
🇺🇸
Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
Seattle Children's Hospital, Seattle, Washington, United States

and more 5 locations

CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy

Phase 2

Completed

Conditions: Familial Partial Lipodystrophy
Nonalcoholic Steatohepatitis
NAFLD

Interventions: Drug: Metreleptin

First Posted Date: 2016-01-13

Last Posted Date: 2020-11-24

Lead Sponsor: University of Michigan

Target Recruit Count: 11

Registration Number: NCT02654977

Locations: 🇺🇸
University of Michigan, Ann Arbor, Michigan, United States

Expanded Access Metreleptin Study

Conditions: Familial Partial Lipodystrophy

First Posted Date: 2015-04-01

Last Posted Date: 2024-04-18

Lead Sponsor: University of Michigan

Registration Number: NCT02404896

Locations: 🇺🇸
University of Michigan, Ann Arbor, Michigan, United States

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