Clinical trials: Lipids Metabolism
Neuronal Ceroid Lipofuscinosis
Study of HuCNS-SC Cells in Patients With Infantile or Late Infantile Neuronal Ceroid Lipofuscinosis (NCL)
Patients with infantile or late infantile NCL have either a reduced amount of, or are missing, the palmitoyl protein thioesterase 1 (PPT1) enzyme or the tripeptidyl peptidase 1 (TPP-I) enzyme.
- Trial name
- NCT00337636
- Testing
- Surgery to implant human CNS stem cells (HuCNS-SC), Medication to suppress the immune system
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- StemCells, Inc.
Neuronal Ceroid Lipofuscinosis Type 2
A Registrational Study of TTX-381 to Treat Vision Loss in CLN2 Disease
This is a registrational, first-in-human, open-label, dose escalation and expansion study evaluating the safety, tolerability and effectiveness of TTX-381, administered by injection under the retina, for the treatment of eye…
- Trial name
- NCT05791864
- Testing
- TTX-381
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Tern Therapeutics, LLC
Fabry Disease
Agalsidase Beta Long-Term Treatment Outcome for Fabry Disease Patients With IVS4 Mutation in Taiwan
This is a national, multicenter, observational, cohort study designed to assess clinical outcomes upon agalsidase beta treatment, to characterize the clinical manifestations, and to collect the natural history on male and female…
- Trial name
- NCT06052800
- Where
- 5 sites in Taiwan
- Volunteers
- 78 people
- Sponsor
- Sanofi
Hypercholesterolemia, Familial, LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA
Safety and Efficacy of the DALI LDL-adsorber and MONET Lipoprotein Filter
Low Density Lipoprotein (LDL)-apheresis refers to a procedure in which blood taken from a patient's vein is cleaned from pathogenic substances, e.g. cholesterol, outside the body and then given back to the patient.
- Trial name
- LINET (NCT01753232)
- Testing
- DALI-adsorber, MONET-Lipoprotein filter
- Where
- 11 sites in Germany
- Volunteers
- 108 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Niemann-Pick Disease, Type C
N-Acetyl-L-Leucine for Niemann-Pick Disease, Type C (NPC)
This is a multinational, multicenter, open-label, rater-blinded prospective Phase II study which will assess the safety and efficacy of N-Acetyl-L-Leucine (IB1001) for the treatment of Niemann-Pick type C disease (NPC).
- Trial name
- NCT03759639
- Testing
- IB1001
- Where
- 9 sites in United States, Germany and 3 more
- Volunteers
- 33 people
- Sponsor
- IntraBio Inc
Heart Failure, High Blood Pressure
BVA-200 vs BVA-100 Validation Study
The proposed study is a prospective, observational, investigator and patient blinded study comparing the results of blood volume measurement using the FDA-cleared Daxor BVA-100 device to the Daxor BVA-200 device.
- Conditions
- Heart Failure, High Blood Pressure, High Cholesterol, Anemia
- Trial name
- NCT06227819
- Testing
- BVA-200
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Daxor Corporation
Hyperlipidemia
A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet
People who follow a low-carbohydrate diet typically experience a decrease in triglycerides and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients may require lipid-lowering therapy.
- Trial name
- LOCUST (NCT00566267)
- Testing
- simvastatin 20 mg/ezetimibe
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia, Dyslipidemias
Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels
The goal of this clinical trial is to find out if lipodia, a digital health intervention, can help lower cholesterol levels and improve other health measures in adults with high cholesterol.
- Trial name
- DIGICHOL (NCT05988866)
- Testing
- lipodia
- Where
- Germany
- Volunteers
- 278 people
- Sponsor
- Gaia AG
Hyperlipidemia
Specified Drug-use Survey of the Granular Capsule Formulation of Omega-3 Fatty Acid Ethyl Esters: OCEAN3
The purpose of this survey is to determine the incidence rate of cardiovascular (CV) events associated with long-term treatment with and without omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in high-risk…
- Trial name
- NCT02285166
- Testing
- Omega-3 fatty acid ethyl esters, Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga).
- Where
- 2 sites in Japan
- Volunteers
- 15,330 people
- Sponsor
- Takeda
Prediabetes, Type 2 Diabetes
Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes
Given the data on the active ingredients of Totum-63, this research aims to evaluate the effect of its chronic consumption (24 weeks) on glucose and lipid homeostasis and especially on fasting plasma glucose in volunteers with…
- Conditions
- Prediabetes, Type 2 Diabetes, Hypertriglyceridemia, Obesity
- Trial name
- TOTUM-63 TWO (NCT02868177)
- Testing
- Totum-63
- Where
- 6 sites in France, Ireland and 2 more
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Valbiotis
Hypertriglyceridemia
Single-ascending Dose Study of Kylo-12 in Healthy Subjects
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-12 will be evaluated in approximately 50 subjects to assess safety, tolerability, pharmacokinetics…
- Trial name
- NCT06783881
- Testing
- Kylo-12
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Kylonova (Xiamen) Biopharma co., LTD.
Hypercholesterolaemia
Rosuvastatin Calcium Bioequivalence Study - Fast
This is an open-label, randomized, two treatment, two sequences, two periods crossover study, using a crossover 2x2 design, where each subject will be randomly assigned to reference or test formulation, in order to evaluate if…
- Trial name
- NCT01711749
- Testing
- Crestor®, rosuvastatin calcium tablets
- Where
- Brazil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hypertriglyceridemia
Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis
The primary objective of the study is to determine the proportion of patients with elevated triglycerides (TG), without familial chylomicronemia syndrome (FCS) due to loss of function (LoF) mutations in lipoprotein lipase (LPL)…
- Trial name
- NCT04863014
- Testing
- evinacumab
- Where
- 39 sites in United States, Canada and 2 more
- Volunteers
- 21 people
- Sponsor
- Regeneron Pharmaceuticals
Generalized Lipodystrophy
Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
The primary objectives of the study are to estimate the effects of REGN4461 on glycemic parameters in the subset of patients with elevated baseline hemoglobin A1c levels (HbA1c ≥7%) and to estimate the effects of REGN4461 on…
- Trial name
- NCT04159415
- Testing
- Low-Dose REGN4461, High-dose REGN4461
- Where
- 8 sites in United States, Peru and 2 more
- Volunteers
- 16 people
- Sponsor
- Regeneron Pharmaceuticals
Metabolic Syndrome, Dyslipidemia
Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid Metabolism
The purpose of this study is to investigate if daily consumption of barley beta-glucans effect lipid and glucose metabolism and alter intestinal microbiota composition in participants with metabolic syndrome or with high risk for…
- Conditions
- Metabolic Syndrome, Dyslipidemia, Obesity, Abdominal, Hyperglycemia
- Trial name
- NCT02041104
- Testing
- Bread with added beta-glucans
- Where
- 3 sites in Slovenia
- Volunteers
- 51 people
- Sponsor
- Mlinotest Zivilska Industrija d.d.
Generalized Lipodystrophy
Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy
MYALEPT™ (metreleptin) has been approved as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (MYALEPT Prescribing…
- Trial name
- NCT04026178
- Testing
- Metreleptin
- Where
- 8 sites in United States
- Volunteers
- 11 people
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Dyslipidemia
A Study of the Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects (0000-108)(COMPLETED)
This is a 2-part pilot study in healthy male subjects to evaluate plasma enrichment kinetics of [13C3,4]-cholesterol (Part I) and to assess the test-retest reproducibility (Part II) of Reverse Cholesterol Transport (RCT)…
- Trial name
- NCT01101763
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Lysosomal Storage Disease, Metachromatic Leukodystrophy
A Safety and Efficacy Study of Cryopreserved OTL-200 for Treatment of Metachromatic Leukodystrophy (MLD)
OTL-200 is autologous CD34+ cells transduced with lentiviral vector containing human arylsulfatase A (ARSA) complementary deoxyribonucleic acid (cDNA) used for the treatment of MLD.
- Trial name
- NCT03392987
- Testing
- OTL-200
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- Orchard Therapeutics
Gaucher's Disease Type III
Study to Evaluate the Efficacy and Safety of Venglustat in Adult and Pediatric Patients With Gaucher Disease Type 3
This is a parallel arm, Phase 3, double-blind, double-dummy, active-comparator, 2 arm study to evaluate the efficacy and safety of daily oral venglustat versus intravenous Cerezyme infusions every two weeks for improvement or…
- Trial name
- LEAP2MONO (NCT05222906)
- Testing
- Venglustat, imiglucerase
- Where
- 22 sites in United States, Argentina and 9 more
- Volunteers
- 43 people
- Sponsor
- Sanofi
Hypercholesterolemia, Mixed Dyslipidemia
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2…
- Conditions
- Hypercholesterolemia, Mixed Dyslipidemia, Type 2 Diabetes
- Trial name
- BANTING (NCT02739984)
- Testing
- Evolocumab
- Where
- 66 sites in United States, Belgium and 5 more
- Volunteers
- 424 people
- Sponsor
- Amgen
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