265. Lipodystrophy Clinical trials / Disease details
Clinical trials : 116 / Drugs : 170 - (DrugBank : 61) / Drug target genes : 26 - Drug target pathways : 97
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05088460 (ClinicalTrials.gov) | January 24, 2022 | 12/10/2021 | A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD) | A Randomized Double-Blind Placebo-Controlled Study of the LEPR Agonist Antibody REGN4461 for the Treatment of Metabolic Abnormalities in Patients With Familial Partial Lipodystrophy | Familial Partial Lipodystrophy;Metabolic Abnormalities | Drug: REGN4461;Drug: Matching Placebo | Regeneron Pharmaceuticals | NULL | Not yet recruiting | 18 Years | N/A | All | 40 | Phase 2 | NULL |
| 2 | NCT04159415 (ClinicalTrials.gov) | January 7, 2020 | 7/11/2019 | Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy | A Randomized, Double-Blind, Placebo-Controlled Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy | Generalized Lipodystrophy | Drug: Placebo;Drug: Low-Dose REGN4461;Drug: High-dose REGN4461 | Regeneron Pharmaceuticals | NULL | Active, not recruiting | 12 Years | N/A | All | 16 | Phase 2 | United States;Peru;Russian Federation;Turkey |
| 3 | EUCTR2017-003014-22-AT (EUCTR) | 25/06/2018 | 29/05/2018 | Leptin in hepatic lipid metabolism in humans | The role of leptin in regulating hepatic lipid metabolism in humans - Leptin and hepatic lipid metabolism | lipodystrophy patients, patients after liver transplantation and healthy controls;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Myalept Product Name: Myalept INN or Proposed INN: metrelpetin Other descriptive name: METRELEPTIN | Medical University of Vienna | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 43 | Phase 2 | Austria | ||
| 4 | NCT03262610 (ClinicalTrials.gov) | February 17, 2017 | 22/8/2017 | Setemelanotide in a Single Patient With Partial Lipodystrophy | Expanded-access for the Use of Setemelanotide in a Single Patient With Partial Lipodystrophy (LD) Associated With Leptin Deficiency and Multiple Autoimmune Diseases | Hypertriglyceridemia | Drug: Setmelanotide | Rhythm Pharmaceuticals, Inc. | NULL | No longer available | 15 Years | 15 Years | Female | United States | ||
| 5 | NCT02654977 (ClinicalTrials.gov) | September 29, 2015 | 20/1/2015 | CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy | CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Recombinant Human Leptin (METRELEPTIN) in Various Forms of Partial Lipodystrophy | Familial Partial Lipodystrophy;Nonalcoholic Steatohepatitis;NAFLD | Drug: Metreleptin | University of Michigan | NULL | Completed | 5 Years | N/A | All | 11 | Phase 2 | United States |
| 6 | NCT01778556 (ClinicalTrials.gov) | January 26, 2013 | 26/1/2013 | Short-term Effects of Leptin in People With Lipodystrophy | Short Term Effects of Leptin Withdrawal or Initiation in Lipodystrophy Independent of Energy Intake | Lipodystrophy | Biological: Metreleptin | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | 14 Years | 70 Years | All | 25 | Phase 2 | United States |
| 7 | NCT01679197 (ClinicalTrials.gov) | October 8, 2012 | 31/8/2012 | Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy | Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy | Fatty Liver Disease, Nonalcoholic;Nonalcoholic Steatohepatitis;Lipodystrophy | Drug: Metreleptin | University of Michigan | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 5 Years | N/A | All | 23 | Phase 2 | United States |
| 8 | JPRN-UMIN000002818 | 2010/08/01 | 01/01/2010 | Phase 2 trial of leptin-replacement therapy for patients with lipodystrophy | lipodystrophy | administration of recombinant methionyl human leptin | Department of Medicine and Clinical Science, Kyoto University Graduate School of MedicineTranslational Research Center, Kyoto University Hospital | NULL | Complete: follow-up complete | 6years-old | Not applicable | Male and Female | 3 | Phase 2 | Japan | |
| 9 | JPRN-UMIN000003679 | 2010/08/01 | 01/06/2010 | Long-term safety clinical trial of leptin-replacement therapy in patients with lipodystrophy after introduction of the treatment | lipodytrophy | subcutaneous injection of human recombinant leptin | Kyoto University Hospital | NULL | Complete: follow-up complete | 6years-old | Not applicable | Male and Female | 11 | Not selected | Japan | |
| 10 | NCT00362440 (ClinicalTrials.gov) | August 2006 | 9/8/2006 | Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome | A Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome: A Randomized, Double-blind, Placebo-controlled Clinical Trial | HIV Lipodystrophy | Drug: Leptin;Drug: Pioglitazone or metformin;Drug: Placebo | Beth Israel Deaconess Medical Center | American Diabetes Association | Completed | 18 Years | N/A | All | 9 | Phase 2 | United States |
| 11 | NCT00896298 (ClinicalTrials.gov) | April 2006 | 8/5/2009 | Trial of Leptin Replacement Therapy in Patients With Lipodystrophy | Double-Blind, Placebo-Controlled Trial of Leptin Replacement Therapy in Patients With Lipodystrophy | Hypoleptinemia;Generalized Lipodystrophy;Partial Lipodystrophy;Insulin Resistance | Drug: Leptin;Drug: Placebo | University of Texas Southwestern Medical Center | NULL | Completed | 6 Years | 70 Years | All | 25 | Phase 2/Phase 3 | United States |
| 12 | NCT01511016 (ClinicalTrials.gov) | February 2003 | 11/1/2012 | Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome | The Effect of Leptin Therapy on Abnormal Lipid Kinetics in Subjects With HIV Lipodystrophy Syndrome | HIV Lipodystrophy | Drug: Human recombinant leptin (metreleptin);Drug: Placebo | Baylor College of Medicine | NULL | Completed | 18 Years | 64 Years | Male | 17 | N/A | United States |
| 13 | NCT00461552 (ClinicalTrials.gov) | January 2003 | 16/4/2007 | Therapeutic Approaches to HAART-Induced Lipodystrophy | Therapeutic Approaches to HAART-Induced Lipodystrophy | HIV Infections;Lipodystrophy | Drug: Leptin;Other: Placebo | University of Texas Southwestern Medical Center | Amylin Pharmaceuticals, LLC. | Completed | 14 Years | 65 Years | All | 23 | Phase 2 | United States |
| 14 | NCT00140244 (ClinicalTrials.gov) | December 2001 | 30/8/2005 | Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome | Role of Leptin in Highly Active Antiretroviral Therapy (HAART)-Induced Lipodystrophy and Metabolic Syndrome in HAART-Treated HIV Patients | HAART-induced Lipodystrophy and Metabolic Syndrome | Drug: r-metHuLeptin;Drug: Placebo | Beth Israel Deaconess Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);Amgen | Completed | 18 Years | N/A | All | 7 | Phase 2 | United States |
| 15 | NCT00025883 (ClinicalTrials.gov) | October 2001 | 27/10/2001 | Leptin to Treat Lipodystrophy | Long-Term Efficacy of Leptin Replacement in Treatment of Lipodystrophy | Lipodystrophy | Drug: Metreleptin | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | 6 Months | N/A | All | 103 | Phase 2 | United States |
| 16 | NCT00005905 (ClinicalTrials.gov) | June 2000 | 9/6/2000 | Leptin to Treat Lipodystrophy | Efficacy of Leptin Replacement in Treatment of Lipodystrophy | Lipodystrophy | Drug: hu Leptin (A-100) | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | N/A | N/A | Both | 20 | Phase 2 | United States |