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
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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
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=5 Study of Gemcabene in Adults With FPLD
Familial Partial Lipodystrophy · Hypertriglyceridemia · Fatty Liver
Primary: Change in Fasting Serum Triglyceride (at 12 Weeks) — -0.44; -20.27 percent change — p=0.517
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
N/A N=11 Familial Hyperlipidemia Family Registry
Familial Hyperlipidemia
Primary: Familial Hypercholesterolemia (FH) Determination for Family Members of School Children With Elevated Cholesterol and Documented FH Variant — 3; 8 participants
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
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
N/A N=41 Fatty Acid Oxidation Defects and Insulin Sensitivity
Very Long-chain Acyl-CoA Dehydrogenase Deficiency · Trifunctional Protein Deficiency · Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency
Primary: Glucose Disposal Rate (Rd)- the Rate of Glucose Infusion to Maintain Euglycemia During Steady State Insulin Infusion in mg/Min — 709; 429; 842; 497 mg/min — p=0.136
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 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=2 Orlistat for the Treatment of Type I Hyperlipoproteinemia
Hyperlipoproteinemia Type I · Hypertriglyceridemia
Primary: Fasting Serum Triglycerides — 705; 1827; 1511; 1007 mg/dL
Phase 2 N=18 Cholic Acid for Hepatic Steatosis in Lipodystrophy
Hepatic Steatosis
Primary: Hepatic Triglyceride (%) — 15.9; 14.8 Fat/Fat+Water (%) — p=0.42
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
N/A N=27 Effects of PPAR Ligands on Ectopic Fat Accumulation and Inflammation
Metabolic Syndrome X · Prediabetic State
Primary: Insulin Sensitivity — 1.48; 1.73; 1.89; 2.93 mg*kg^-1*min^-1
N/A N=40 Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly
Acromegaly
Primary: Change in Liver Fat — 0.03 Lipid/water ratio
Phase 2 N=53 Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
Nonalcoholic Fatty Liver Disease (NAFLD)
Primary: Change in Intrahepatic Lipid Content Between Baseline and 6 Months as Measured by 1H-magnetic Resonance Spectroscopy (1H-MRS). Endpoints Were Assessed at Baseline and 6…
N/A N=4 Metabolomic Analysis of Hepatic Insulin Resistance
Type 2 Diabetes · Obesity
Primary: Insulin Sensitivity — 8 m value — p=<0.05
N/A N=90 Fibroblast Growth Factors 19 and 21 in Gestational Diabetes Mellitus
Gestational Diabetes Mellitus
Primary: The Concentration of Serum FGF19 — 65.96; 124.47 pg/mL
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 Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS)
Familial Chylomicronemia Syndrome · Lipoprotein Lipase Deficiency · Hyperlipoproteinemia Type 1
Primary: Absolute Change From Baseline to Month 3 in Fasting Triglycerides (TG) — -550.00 mg/dL
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=106 Lipid Metabolism in Gestational Diabetes
Gestational Diabetes · Hyperlipidemia
Primary: Cholesterol — 204; 201 mg/dl
Phase 2 N=12 Evaluation of 3-V Bioscience-2640 to Reduce de Novo Lipogenesis in Subjects With Characteristics of Metabolic Syndrome
Metabolic Syndrome
Primary: Change in Hepatic Lipogenesis — 5.6 abs percent change fasting lipogenesis
N/A N=157 Defective Atypical Protein Kinase C (PKC) Activation in Diabetes and Metabolic Syndrome
Diabetes Mellitus, Type 2
Primary: Alterations in PKC-zeta mRNA in Vastus Lateralis Skeletal Muscles — 1.76; 3.58; 2.14; 2.22 arbitrary units/ng rRNA — p=.001
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=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
Phase 2 N=71 Rosiglitazone Effect on Mitochondria and Lipoatrophy
HIV Infections
Primary: Change in Limb Fat at 48 Weeks — 448; 153 grams — p=0.02
Phase 3 N=45 A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome
Familial Chylomicronemia Syndrome (FCS)
Primary: Percent Change in Fasting Triglycerides From Baseline to 12 Weeks — 45.6; 3.7; -13.9 percent change — p=0.0538