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
-

MEASuRE: Metreleptin Effectiveness And Safety Registry

First Posted Date
2014-12-25
Last Posted Date
2024-11-18
Lead Sponsor
Aegerion Pharmaceuticals, Inc.
Target Recruit Count
100
Registration Number
NCT02325674
Locations
🇫🇷

Hôpital Robert Debré, Paris, Paris, France, France

🇺🇸

University Alabama at Birmingham, Birmingham, Alabama, United States

🇺🇸

City of Hope, Duarte, California, United States

and more 24 locations

Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2014-10-13
Last Posted Date
2024-11-26
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
30
Registration Number
NCT02262806
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy

Phase 3
Recruiting
Conditions
Interventions
First Posted Date
2014-10-13
Last Posted Date
2024-08-28
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
30
Registration Number
NCT02262832
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy

First Posted Date
2012-09-05
Last Posted Date
2017-06-14
Lead Sponsor
University of Michigan
Target Recruit Count
23
Registration Number
NCT01679197
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2008-05-14
Last Posted Date
2015-04-30
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
41
Registration Number
NCT00677313
Locations
🇺🇸

Research Site, Greenville, North Carolina, United States

🇺🇸

Local Institution, Reno, Nevada, United States

Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects

First Posted Date
2008-05-07
Last Posted Date
2015-04-15
Lead Sponsor
AstraZeneca
Target Recruit Count
636
Registration Number
NCT00673387
Locations
🇺🇸

Research Site, Olympia, Washington, United States

Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2008-01-17
Last Posted Date
2017-11-24
Lead Sponsor
Elif Oral
Target Recruit Count
9
Registration Number
NCT00596934
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects

First Posted Date
2006-10-26
Last Posted Date
2015-04-14
Lead Sponsor
AstraZeneca
Target Recruit Count
177
Registration Number
NCT00392925
Locations
🇺🇸

Research Site, Olympia, Washington, United States

Role of Leptin in the Neuroendocrine and Immune Response to Fasting

Phase 1
Completed
Conditions
Interventions
First Posted Date
2005-09-01
Last Posted Date
2017-06-07
Lead Sponsor
Beth Israel Deaconess Medical Center
Target Recruit Count
13
Registration Number
NCT00140231
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome

First Posted Date
2005-09-01
Last Posted Date
2017-05-11
Lead Sponsor
Beth Israel Deaconess Medical Center
Target Recruit Count
7
Registration Number
NCT00140244
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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