| Myalept (metreleptin) / Novelion |
NCT06484868: Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy |
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| Recruiting | 4 | 12 | Europe | Metreleptin | Amryt Pharma | Partial Lipodystrophy | 09/27 | 09/27 | | |
NCT04026178: Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy |
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| Active, not recruiting | 4 | 10 | US | Metreleptin | Aegerion Pharmaceuticals, Inc. | Generalized Lipodystrophy | 10/24 | 04/25 | | |
| Recruiting | 3 | 15 | US | Metreleptin | Amryt Pharma | Familial Partial Lipodystrophy | 03/28 | 03/28 | | |
NCT06548100: A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD) |
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| Recruiting | 3 | 8 | US | mibavademab, REGN4461 | Regeneron Pharmaceuticals | Generalized Lipodystrophy | 03/27 | 07/27 | | |
NCT06502990: Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy |
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| Recruiting | 3 | 15 | Europe | Metreleptin | Amryt Pharma | Generalized Lipodystrophy | 09/26 | 09/26 | | |
METRE-PL, NCT05164341: Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects with PL |
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| Recruiting | 3 | 65 | Europe, Canada, US, RoW | metreleptin, Placebo | Amryt Pharma | Partial Lipodystrophy | 06/25 | 01/26 | | |
NCT02262832: Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy |
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| Recruiting | 3 | 30 | US | Metreleptin | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Lipodystrophy, Diabetes, Hyperlipidemia | 07/25 | 07/25 | | |
2017-003014-22: Leptin in hepatic lipid metabolism in humans Leptin und der Leberfettsoffwechsel |
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| Ongoing | 2 | 43 | Europe | Myalept, Concentrate and solvent for solution for injection, Myalept | Medical University of Vienna, Medical University of Vienna | lipodystrophy patients, patients after liver transplantation and healthy controls, patients suffering from partial or total disease of fat storage in adipose tissue patients with liver transplanthealthy controls, Diseases [C] - Nutritional and Metabolic Diseases [C18] | | | | |
NCT00085982: Effect of Metreleptin Therapy in the Treatment of Severe Insulin Resistance |
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| Active, not recruiting | 2 | 11 | US | Metreleptin | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Severe Insulin Resistance | 10/19 | 01/30 | | |
NCT05351164: Evaluation of Safety and Efficiency of Metreleptin Treatment for Patients With Multiple Symmetric Lipomatosis (MSL) |
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| Active, not recruiting | 2 | 4 | US | Metreleptin | University of Michigan, Amryt Pharma | Lipomatosis, Multiple Symmetrical | 04/24 | 04/25 | | |
| Recruiting | 2 | 50 | Europe | Metreleptin, Myalept®, Sodium chloride | Gabriella Milos | Anorexia Nervosa | 02/26 | 02/26 | | |
NCT02262806: Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy |
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| Active, not recruiting | 2 | 30 | US | Metreleptin | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Diabetes, Lipodystrophy, Hyperlipidemia | 07/25 | 07/25 | | |
| Available | N/A | | US | Metreleptin, MyaLept | University of Michigan | Familial Partial Lipodystrophy | | | | |
NCT00691158: A Study of the Functional Magnetic Resonance Imaging Response to Leptin and Pramlintide |
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| Active, not recruiting | N/A | 10 | US | Pramlintide (Amylin), Amylin, Placebo (Normal Saline), Placebo, 2 Metreleptin, Leptin, Leptin plus Pramlintide, Leptin and Amylin | Oregon Health and Science University | Obesity | 07/24 | 07/24 | | |
NCT05419037: Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy |
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| Recruiting | N/A | 90 | US | | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Lipodystrophy | 03/25 | 03/25 | | |
| Recruiting | N/A | 100 | Europe, US | Metreleptin | Aegerion Pharmaceuticals, Inc. | Generalised Lipodystrophy, Partial Lipodystrophy | 10/31 | 10/31 | | |
| mibavademab (REGN4461) / Regeneron |
2021-000138-33: A study to examine the effects of the LEPR Agonist Antibody REGN4461 in patients with Familial Partial Lipodystrophy Estudio para analizar los efectos de REGN4461, un anticuerpo agonista del LEPR, en pacientes con lipodistrofia parcial familiar |
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| Not yet recruiting | 2 | 40 | Europe | REGN4461, REGN4461, Lyophilisate for solution for infusion, Lyophilisate for solution for injection | Regeneron Pharmaceuticals, Inc., Regeneron Pharmaceuticals, Inc. | Familial Partial Lipodystrophy Lipodistrofia Parcial Familiar, Familial Partial Lipodystrophy Lipodistrofia Parcial Familiar, Diseases [C] - Nutritional and Metabolic Diseases [C18] | | | | |
NCT04159415: Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy |
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| Completed | 2 | 16 | US, RoW | Placebo, Low-Dose REGN4461, mibavademab, High-dose REGN4461 | Regeneron Pharmaceuticals | Generalized Lipodystrophy | 01/22 | 09/24 | | |
NCT06373146: A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity |
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| Recruiting | 2 | 360 | US, RoW | Tirzepatide, LY3298176, Mibavademab, REGN4461, Tirzepatide-Placebo, Mibavademab-Placebo | Eli Lilly and Company, Regeneron Pharmaceuticals | Obesity | 12/25 | 04/26 | | |
LEAP, NCT05088460 / 2021-000138-33: A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD) |
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| Terminated | 2 | 20 | Europe, US, RoW | REGN4461, mibavademab, Matching Placebo | Regeneron Pharmaceuticals, Regeneron Pharmaceuticals, Inc. | Familial Partial Lipodystrophy, Metabolic Abnormalities | 12/23 | 04/24 | | |
NCT04710056: Expanded Access to REGN4461 for Patients With Lipodystrophy or Monogenic Obesity With Complications of Leptin Deficiency or Deficient Leptin Signaling |
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| Available | N/A | | NA | REGN4461, mibavademab | Regeneron Pharmaceuticals | Generalized Lipodystrophy, Partial Lipodystrophy, Monogenic Obesity Due to LEP or LEPR Loss of Function | | | | |
| ERX1000 / ERX Pharmaceuticals |
NCT04890873: ERX1000 - Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Male and Female Subjects With Obesity |
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| Completed | 1 | 48 | US | ERX1000, Placebo, Magnesium hydroxide carbonate | ERX Pharmaceuticals | Obesity | 07/23 | 07/23 | | |
