Phase 2 N=25 Short-term Effects of Leptin in People With Lipodystrophy
Lipodystrophy
Primary: Total Body Insulin Sensitivity — 4.4; 10.9; 5.8; 6.4 mg/kg fat-free mass/min
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Phase 2 N=5 Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension
Lipodystrophy
Primary: Change in Log 10 Fasting Triglycerides. — 0.1; -0.2 log 10 mg/dl
Phase 2 N=103 Leptin to Treat Lipodystrophy
Lipodystrophy
Primary: Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin — 8.4; 8.1; 6.6; 7.2 percentage of glycated hemoglobin — p=<0.001
Phase 4 N=56 Mechanisms of Lipodystrophy in HIV-Infected Pateints
HIV Infections
Primary: Effect of Drug Regimens on Serum Triglycerides. — 228.0; 230.4; 293.4; 290.0 mg/dL — p=0.94
N/A N=4 HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone)
HIV Infections
Primary: Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg
Phase 2 N=23 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
Primary: Liver Histopathology — 6; 5 units on a scale
N/A N=17 Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome
HIV Lipodystrophy
Primary: Rate of Total Lipolysis — 0.649; 0.767 mmol FFA/kg/h
Phase 2 N=11 CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy
Familial Partial Lipodystrophy · Nonalcoholic Steatohepatitis · NAFLD
Primary: Percent Change in Fasting Triglyceride Levels — 55.76 percentage of change from baseline
Phase 4 N=11 Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy
Generalized Lipodystrophy
Primary: Evaluate the Immunogenicity Associated With Daily Subcutaneous (SC) Metreleptin Treatment in Patients With Congenital Generalized Lipodystrophy (CGL) or Acquired…
Phase 2 N=7 Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome
HAART-induced Lipodystrophy and Metabolic Syndrome
Primary: Serum Lipid Levels — 228.8; 219.7; 113.0; 105.7 mg/dl
Phase 3 N=25 Trial of Leptin Replacement Therapy in Patients With Lipodystrophy
Hypoleptinemia · Generalized Lipodystrophy · Partial Lipodystrophy
Primary: Fasting Serum Triglycerides — 203; 304 mg/dL — p=0.2572
Phase 2 N=14 Therapeutic Approaches to HAART-Induced Lipodystrophy
HIV Infections · Lipodystrophy
Primary: Fasting Serum Triglycerides — 237; 341 mg/dL — p=0.84
Phase 2 N=10 Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients
Familial Partial Lipodystrophy
Primary: Change in the Liver Triglycerides (TG). — 13.2; 6.4; 12.3; 10.6 percentage of liver triglycerides
N/A N=221 Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia
Cardiovascular Diseases · Heart Diseases · HIV Infections
Primary: Triglycerides — 199; 216.9; 155.1; 177.6 mg/dL
Phase 2 N=4 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Partial Lipodystrophy (FPL)
Familial Partial Lipodystrophy
Primary: Percent Change From Baseline in Fasting Triglycerides Levels at End of the Treatment (Week 27) — -59.9 percent change