K-924 Phase III Confirmatory Study
HypercholesterolemiaA multicenter, active-controlled, randomized, double-blind comparative study to compare the efficacy and safety of K-924 LD tablet or K-924 HD tablet to pitavastatin 2 mg or 4 mg in patienta with hypercholesterolemia.
A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH
Homozygous Familial HypercholesterolemiaAK102 is being developed for the treatment of HoFH. The study will be conducted in 2 parts, part 1 is open label, single arm study to evaluate the safety, tolerability and efficacy of PCSK9 inhibitor AK102, and part 2 is double blind, randomized, placebo controlled study to evaluate the efficacy and safety of PCSK9 inhibitor AK102. The treatment period will last 12 week.
Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia...
Primary HypercholesterolemiaThe purpose of this study is to evaluate efficacy and safety of HL140 in patients with primary hypercholesterolemia.
The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed...
HyperlipemiaJS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of JS002 prefilled syringes and prefilled autosyringes in patients with primary hypercholesterolemia and mixed hyperlipidemia when combined with statin therapy. In this study, one dose group (150 mg) were set up in this study. 240 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 :2:1ratio of JS002 PFS / placebo or JS002 AI / placebo ). Each subject required a maximum of 6 weeks of screening, 12 weeks of treatment, and 8 weeks of follow-up.
Effects of a Single Dose of Brazil Nuts on Blood Lipids
Cholesterol LevelHighSeveral studies have shown that regular intake of nuts may improve blood lipids. However, few studies have investigated the effects on blood lipids after a single intake of nuts. The present study was conducted in order to evaluate the acute effects of a single intake of Brazil nuts on blood lipids. The study was a non-blinded randomized controlled study with 52 participants, 26 participants in both the Brazil nut group and in the control group. Blood tests were taken at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of either 50g Brazil nuts or an isocaloric amount of coconut flakes. We then conducted an unpaired t-test in order to compare changes in blood lipids between the two groups. P-values < 0.05 were considered statistically significant
A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia
HypercholesterolemiaThe purpose of this study is to assess the low-density lipoprotein cholesterol (LDL-C)-lowering efficacy and safety of ETC-1002(bempedoic acid) 60 mg, 120 mg and 180 mg versus placebo added to ongoing stable statin therapy or other lipid-modifying therapies in Japanese patients with hypercholesterolemia treated for 12 weeks.
Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary...
Primary HypercholesterolemiaMixed DyslipidemiasThe study is to evaluate whether the efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia in the 12 week treatment period.
Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Hypercholesterolemia
HypercholesterolemiaThe joint ESC/EAS guidelines for the management of dyslipidaemias recommend, for patients at low/moderate CV risk with raised LDL-C, a set of measures collectively defined as "lifestyle interventions", with use of drugs only if the LDL-C levels cannot be controlled with such lifestyle interventions. "Lifestyle interventions" also includes food supplements. The reason is the following: a simple "dietary advice" has been shown (Cochrane review and meta-analysis, Rees et al, 2013) to achieve a modest reduction of total-C and LDL-C. The review reports: Dietary advice reduced total serum cholesterol by 0.15 mmol/L (95% CI 0.06 to 0.23) and LDL cholesterol by 0.16 mmol/L (95% CI 0.08 to 0.24) after 3 to 24 months." An average reduction of LDL-C by 0.16 mmol/L (6.2 mg/dL) is definitely insufficient to control the level of LDL-C in those subjects. Therefore, those subjects would lose motivation to keep dieting. In this context, use of supplements would significantly amplify the result of diet. A significant proportion of ischemic cardiovascular events are believed to be supported by the coexistence of traditional cardiovascular risk factors such as diabetes, hypertension, dyslipidemia, smoking, and others. The aggregation of these factors is accompanied by a significant increase in the risk of cardiovascular events. Observational studies shown the existence of a relationship between cholesterolemia and coronary heart disease, clearly showing that subjects with even modestly increased total cholesterol values over time develop both fatal and non-fatal vascular events with a higher frequency compared to subjects with similar characteristics, but with lower basal values of cholesterol. Numerous controlled intervention studies, on the other hand, have shown that there is a close correlation between cholesterol reduction and cardiovascular risk; in fact, reductions in the plasma concentration of total and LDL-C, obtained through lifestyle modification or specific drugs, result in reductions in the incidence of major coronary events. The effectiveness of these interventions has been demonstrated both in subjects in primary prevention and in patients in secondary prevention.
Study of SHR-1209 in the Treatment of Hypercholesterolemia and Hyperlipidemia Ⅲ Stage
Primary HypercholesterolemiaMixed HyperlipemiaThe study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia and hyperlipemia.
Supplements, Placebo, or Rosuvastatin Study
HypercholesterolemiaA research study that is evaluating a low dose of an FDA approved statin medication in comparison to several commercially available over the counter dietary supplements which are marketed for cholesterol health. The study is comparing their effect on LDL cholesterol. LDL-cholesterol is low-density cholesterol and is sometimes referred to as "bad" cholesterol. Participants must live in Ohio and have a documented elevated LDL cholesterol level between 70-189mg/dL, must not currently be taking a statin or one of the dietary supplements included in the trial. Participants willing to discontinue a prohibited supplement for 4 weeks prior to enrollment will be allowed to participate. Trial participation is 4 weeks. Study medication will be provided at no charge. There will be 2 visits which include a lab draw at any Cleveland Clinic laboratory. Participants will be randomized (like a coin flip) to be in one of 8 possible groups: Rosuvastatin, Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice, or placebo. The study will enroll 200 participants.