Phase 2 N=1 Effects of Leptin Replacement in Children
Obesity · Metabolic Syndrome · Diabetes
Primary: Weight — NA lbs
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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
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 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=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=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
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 1 N=12 In Vivo Leptin Signaling in Humans After Acute Leptin Administration
Lean · Obese · Obese Diabetics
Primary: Leptin Signaling — 3.1 fold change
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=3 Effects of Human Leptin Replacement
Obesity · Metabolic Syndrome · Diabetes
Primary: Change in Weight — NA lbs
N/A N=28 Dopamine and Insulin Resistance
Obesity
Primary: Striatal DRD2 Receptor Binding — 28; 33; 32; 33 ratio — p=<0.05
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=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 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
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)
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=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 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
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 3 N=15 Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity
Pro-opiomelanocortin (POMC) Deficiency Obesity
Primary: Percentage of Participants Who Reached ≥10% Weight Loss Threshold After 1 Year (Pivotal Cohort) — 80.0 percentage of participants — p=<0.0001
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 3 N=12 Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity
Bardet-Biedl Syndrome · POMC Deficiency Obesity · PCSK1 Deficiency Obesity
Primary: Percentage of Participants With Greater Than or Equal to (≥) 0.2 Reduction of BMI Z-Score From Baseline to Week 52 — 85.7; 80.0 percentage of participants
N/A N=30 Estrogen Sensitivity and Ovulatory Dysfunction in Obesity
Obesity · Infertility
Primary: Luteinizing Hormone Pulse Amplitude — 2.73; 1.12 IU/L
N/A N=62 Reproductive Hormonal Alterations in Obesity
Obesity
Primary: Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1) — 4.1; 3.6 IU/L
N/A N=39 Early-onset Obesity and Cognitive Impairment in Children With Pseudohypoparathyroidism
Pseudohypoparathyroidism · Albright Hereditary Osteodystrophy
Primary: Intelligence Quotient — 85.9; 104.3; 103.2 units on a scale
N/A N=3 Deep Brain Stimulation Effects on Weight Change and Metabolic Rate
Obesity
Primary: Change in Metabolic Rate — 7.6; 18 percentage of increase in REM and SEE
Phase 2 N=18 Open-Label Study of Setmelanotide in Hypothalamic Obesity
Hypothalamic Obesity
Primary: Percentage of Participants With ≥ 5% Reduction in BMI From Baseline After 16 Weeks of Setmelanotide Treatment — 88.9 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
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…
N/A N=180 Apelin Levels and G212A Polymorphism of Apelin Receptor (APJ)
Obesity · Insulin Resistance · Diabetes Mellitus Type 2
Primary: Serum Apelin Levels — 1.45; 1.91 ng/ml — p=0.001