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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=26 Effect of Increased Free Fatty Acids on Leptin Function
Obesity · Leptin Resistance
Primary: Change in Circulating Glucagon-like Peptide-1 (GLP-1) Levels — 7147; 11725; 11898; 28060 pM*min
Phase 2 N=24 Leptin in the Maintenance of Reduced Body Weight
Obesity
Primary: Percent Change From Baseline in Body Weight at 6 Months — 10.2; 12.7 percentage change
Phase 1 N=15 Pharmacokinetics of Leptin Administration During Fasting
Energy Deficiency Due to Short-term Fasting
Primary: Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg — 1.93; 2.75; 2.99; 2.00 HR
Phase 2 N=1 Effects of Leptin Replacement in Children
Obesity · Metabolic Syndrome · Diabetes
Primary: Weight — NA lbs
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
Phase 2 N=13 Role of Leptin in the Neuroendocrine and Immune Response to Fasting
Fasting
Primary: Cortisol — 17.5; 16.9 ug/dl
Phase 1 N=12 In Vivo Leptin Signaling in Humans After Acute Leptin Administration
Lean · Obese · Obese Diabetics
Primary: Leptin Signaling — 3.1 fold change
N/A N=18 Recombinant Human Leptin Therapy Effects on Insulin Action
Type Two Diabetes Mellitus
Primary: Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars. — 14.3; 18.4; 16.7 mmol/kg body weight/minute
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 2 N=20 Study of Leptin for the Treatment of Hypothalamic Amenorrhea
Amenorrhea
Primary: the Difference Between the Placebo and Leptin Treated Groups in the Change in Bone Mineral Content(BMC) at the Anteroposterior (AP) Spine From Baseline to 36 Weeks…
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=3 Effects of Human Leptin Replacement
Obesity · Metabolic Syndrome · Diabetes
Primary: Change in Weight — NA lbs
Phase 2 N=31 Trial of Leptin Administration After Roux-en-Y Gastric Bypass
Overweight
Primary: Weight Change (in kg.) After Each Intervention — -0.39; 0.02 kg weight change
Early Phase 1 N=103 Leptin Infusion and Endothelial Vasomotor Response
Endothelial Dysfunction · Obesity · Vasodilation
Primary: Forearm Blood-flow (FBF) — 1.75; 3.1; NA; NA ml/100 mg tissue/min
Phase 2 N=177 A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects
Overweight · Obesity
Primary: Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population — -2.68; -3.30; -6.46 kg — p=0.0004
N/A N=30 Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents
Obesity
Primary: Peak Growth Hormone (GH) on the GH Stimulation Test — 40.1; 25.2 ng/ml — p=<0.05
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=9 Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome
HIV Lipodystrophy
Primary: Insulin Resistance (HOMA Index) — 1.6; 1.8 units on a scale
Phase 3 N=15 Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity
Leptin Receptor Deficiency Obesity
Primary: Percentage of Participants Who Reached ≥10% Weight Loss Threshold After 1 Year (Pivotal Cohort) — 45.5 percentage of participants — p=0.0001
Phase 2 N=9 Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)
Fatty Liver Disease, Nonalcoholic
Primary: Non-alcoholic Steatohepatitis Score as Determined by Liver Histopathology at 12 Months — 5 units on a scale — p=0.015
N/A N=52 Ghrelin Levels in Children With Poor Growth
Idiopathic Short Stature · Failure to Thrive
Primary: Total Ghrelin Level — 1063; 1264; 1157 pg/mL
Phase 2 N=16 Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
Generalized Lipodystrophy
Primary: Absolute Change From Baseline in Participants With Elevated Baseline Hemoglobin A1c (HbA1c ≥7%) at Week 8 — -0.1; 0.2 millimoles per mole (mmol/mol)
Phase 2 N=608 Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects
Overweight · Obesity
Primary: Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population — -2.01; -5.47; -5.83; -6.85 Percentage change in kg — p=<0.0001
N/A N=78 Salivary and Serum Leptin Levels in Oral Lichen Planus Patients: A Case-control Study.
Oral Lichen Planus · Leptin Levels
Primary: Serum Leptin Level — 13.23; 4.20 ng/ml
Phase 2 N=19 Effects of Exenatide on Hypothalamic Obesity
Hypothalamic Obesity
Primary: BMI Change — -0.77 kg/m^2 — p=.05
Phase 4 N=23 GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response
Glucose Intolerance · Overweight and Obesity · Drug Effect
Primary: Cytokine Interleukin-6 (IL-6) Messenger Ribonucleic Acid (mRNA) Level (From Adipose Tissue) — 7.88; 7.67 natural log(arbitrary units)
N/A N=28 Dopamine and Insulin Resistance
Obesity
Primary: Striatal DRD2 Receptor Binding — 28; 33; 32; 33 ratio — p=<0.05
Phase 3 N=42 Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity
Hypothalamic Obesity
Primary: Percent Change of Body Mass Index (BMI) as Calculated by the Formula: Body Weight in kg Divided by Height in Meters². — 1.7; 3.5 percent change from baseline — p=0.40