Clinical trials: Lipoprotein Disorder
Hyperlipidemia
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as…
- Trial name
- MENDEL (NCT01375777)
- Testing
- Evolocumab, Ezetimibe
- Where
- 58 sites in United States, Australia and 3 more
- Volunteers
- 411 people
- Sponsor
- Amgen
Non-alcoholic Fatty Liver Disease (NAFLD)
How Does Dietary Carbohydrate Influence the Formation of an Atherogenic Lipoprotein Phenotype (ALP)?
The hypothesis of this study is that a diet high in sugars will increase abnormalities in blood lipids which are associated with increased cardiovascular disease risk, relative to a diet which is low in sugar.
- Trial name
- CHOT (NCT01790984)
- Testing
- High sugar low starch diet, Low sugar high starch diet
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Bruce A. Griffin
Hypercholesterolemia, Heterozygous Familial
A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol
Primary objective: Determine whether mipomersen (ISIS 301012) significantly reduces atherogenic lipid levels in patients with severe heterozygous familial hypercholesterolemia (severe HeFH), defined as low-density lipoprotein…
- Trial name
- FOCUS FH (NCT01475825)
- Testing
- mipomersen sodium 200 mg, mipomersen sodium 70 mg
- Where
- 113 sites in United States, Argentina and 28 more
- Volunteers
- 309 people
- Sponsor
- Kastle Therapeutics, LLC
Cardiovascular Disease
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]).
- Trial name
- NCT04270760
- Testing
- Olpasiran
- Where
- 36 sites in United States, Australia and 5 more
- Volunteers
- 281 people
- Sponsor
- Amgen
Hypercholesterolemia
Effect of a Treatment With a Nutraceutical Combination on Sub-optimal LDL Cholesterol Levels
High cholesterol is one of the major controllable risk factor for coronary heart disease. It is well demonstrated that drugs that reduce the intestinal absorption of cholesterol or block the synthesis of cholesterol or the…
- Trial name
- NATCOL (NCT03739242)
- Testing
- Nutraceutical combination
- Where
- Italy
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- A. Menarini Industrie Farmaceutiche Riunite S.r.l.
Endothelial Dysfunction
Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Progenitor Cells and Coronary Atherosclerosis in Humans
AIM III is a prospective, randomized, double-blinded, placebo controlled trial. The study is directly connected to IRB 08-008161 as a specific aim of the National Institute of Health (NIH) grant.
- Trial name
- NCT01067339
- Testing
- darapladib
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Mayo Clinic
Meningococcal B Disease
Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.
The purpose of this study is to investigate the immunogenicity, safety and tolerability of a new vaccine that might prevent meningococcal B disease. The study will be conducted in healthy toddlers aged between 12 and 24 months.
- Trial name
- NCT02534935
- Testing
- rLP2086 vaccine, Pediatric HAV vaccine
- Where
- 25 sites in Australia, Czechia and 2 more
- Volunteers
- 396 people, healthy volunteers welcome
- Sponsor
- Pfizer
Elevated LDL Cholesterol
A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol
This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of…
- Trial name
- NCT01004705
- Testing
- Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),, Simvastatin
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Ferrer Internacional S.A.
Hypercholesterolemia
Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1)
This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol Screening and Treatment project (ACT I), which assessed the cholesterol status, including achievement of the target levels applicable at that…
- Trial name
- ACT II (NCT01381679)
- Testing
- Ezetimibe
- Volunteers
- 1,682 people
- Sponsor
- Organon and Co
Hyperlipidemia
Sitagliptin Regulation of Intestinal and Hepatic Lipoprotein Particle and Hepatic Glucose Production in Humans
Recent studies in both animals and humans has demonstrated that the hormone GLP-1 (glucagon like peptide 1) reduces intestinal production of lipoprotein particles.
- Trial name
- NCT01600703
- Testing
- Sitagliptin
- Where
- Canada
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Obese, Insulin Resistance
Blood Lipopolysaccharide (LPS) Rifaximin Study
Metabolic syndrome is a condition involving elevated levels of fat in the blood, a tendency towards diabetes, hypertension, and too much fat around the abdomen (an increased waistline).
- Conditions
- Obese, Insulin Resistance, Metabolic Syndrome
- Trial name
- NCT02124512
- Testing
- Rifaximin SSD
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Philip Kern
Meningitis, Meningococcal
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control.
- Trial name
- NCT01352793
- Testing
- rLP2086 vaccine, control
- Where
- 86 sites in United States, Australia and 10 more
- Volunteers
- 5,715 people, healthy volunteers welcome
- Sponsor
- Pfizer
Primary Biliary Cirrhosis
Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
The purpose of this study was to determine if OCA had an effect on cholesterol levels in the blood in participants with primary biliary cirrhosis (PBC).
- Trial name
- NCT01865812
- Testing
- Obeticholic Acid
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Intercept Pharmaceuticals
Lipoprotein Metabolism, PCSK9
Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults
Background: Fish oils are known to be beneficial to health and believed to be cardio-protective. Omega-3 fatty acid is the most known fish oil available in the market.
- Conditions
- Lipoprotein Metabolism, PCSK9, Proteomics
- Trial name
- NCT03043365
- Testing
- control fish oil, LCMUFA-rich saury oil
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Metabolic Syndrome
Role of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Inflammation and Lipids
The objective of this study is to provide critical information regarding both common and distinctive roles of EPA and DHA in systemic inflammation and lipid metabolism.
- Trial name
- NCT02670382
- Testing
- EPA, DHA, sunflower oil
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Tufts University
Elevated Lipoprotein(a), Cardiovascular Disease
Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Participants With Hyperlipoproteinemia(a) and Cardiovascular Disease
This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 681257 and to assess the efficacy of different doses and dosing regimens of ISIS…
- Trial name
- NCT03070782
- Testing
- ISIS 681257
- Where
- 32 sites in United States, Canada and 3 more
- Volunteers
- 286 people
- Sponsor
- Akcea Therapeutics
Polycystic Ovary Syndrome
A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol
The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.
- Trial name
- NCT00529542
- Testing
- Lipitor
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Milton S. Hershey Medical Center
Type 2 Diabetes Mellitus
Effects of Pioglitazone on High-density Lipoprotein (HDL) Function in Persons With Diabetes
Metabolic defects contributing to the development of type 2 diabetes (T2D) are relative insulin insufficiency and insulin resistance that are associated with a cluster of abnormalities that increase the risk for cardiovascular…
- Trial name
- NCT01156597
- Testing
- pioglitazone
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Miami
Hyperlipidemia
Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood
The purpose of this study is to explore the effects of 8-week treatment with omega-3-acid ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients receiving a HMG-CoA reductase inhibitor by use of…
- Trial name
- LOTUS (NCT02839902)
- Testing
- TAK-085, Not treated with omega-3-acid ethyl esters
- Where
- 7 sites in Japan
- Volunteers
- 53 people
- Sponsor
- Takeda
Hypercholesterolemia
A Study of LY3015014 in Participants With High Cholesterol
This study is designed to define the amount and duration of cholesterol lowering and to assess the safety and tolerability of different dose regimens of LY3015014 in participants with high cholesterol.
- Trial name
- NCT01890967
- Testing
- LY3015014, Statin, Ezetimibe
- Where
- 49 sites in United States, Canada and 6 more
- Volunteers
- 527 people
- Sponsor
- Eli Lilly and Company