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 | NCT05164341 (ClinicalTrials.gov) | December 2021 | 11/11/2021 | A 12-Month Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Patients With Partial Lipodystrophy | A 12-Month Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Patients With Partial Lipodystrophy | Partial Lipodystrophy | Drug: metreleptin;Drug: Placebo | Amryt Pharma | NULL | Not yet recruiting | 5 Years | N/A | All | 80 | Phase 3 | NULL |
| 2 | NCT04026178 (ClinicalTrials.gov) | November 14, 2018 | 30/10/2018 | Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy | A 36-Month, Multicenter, Open Label Phase 4 Study to Evaluate the Immunogenicity of Daily SC Metreleptin Treatment in Patients With Generalized Lipodystrophy | Generalized Lipodystrophy | Drug: Metreleptin | Aegerion Pharmaceuticals, Inc. | NULL | Recruiting | 1 Year | N/A | All | 10 | Phase 4 | United States |
| 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 | 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 |
| 5 | NCT02262806 (ClinicalTrials.gov) | October 14, 2014 | 9/10/2014 | Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy | Compassionate Use of Metreleptin in Previously-Treated Patients With Partial Lipodystrophy | Diabetes;Lipodystrophy;Hyperlipidemia | Drug: Metreleptin | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Active, not recruiting | 6 Months | N/A | All | 30 | Phase 2 | United States |
| 6 | NCT02262832 (ClinicalTrials.gov) | October 9, 2014 | 10/10/2014 | Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy | Compassionate Use of Metreleptin in Previously-Treated Patients With Generalized Lipodystrophy | Lipodystrophy;Diabetes;Hyperlipidemia | Drug: Metreleptin | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Recruiting | 6 Months | N/A | All | 30 | Phase 3 | United States |
| 7 | 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 |
| 8 | 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 |
| 9 | NCT02404896 (ClinicalTrials.gov) | October 2011 | 20/1/2015 | Expanded Access Metreleptin Study | Expanded-Access for the Use of Metreleptin in Patients With Partial Lipodystrophy Associated With Diabetes Mellitus or Hypertriglyceridemia | Familial Partial Lipodystrophy | Drug: Metreleptin | University of Michigan | NULL | No longer available | 18 Years | N/A | All | United States | ||
| 10 | NCT00677313 (ClinicalTrials.gov) | November 2008 | 12/5/2008 | An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy | An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy | Lipodystrophy | Drug: metreleptin | Bristol-Myers Squibb | NULL | Active, not recruiting | 5 Years | N/A | Both | 41 | N/A | United States |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 |