Hyperlipidemia Clinical Trial
Official title:
The Safety, Tolerability and Efficacy of Multiple Subcutaneous Injections of SHR-1209 in Subjects With Hyperlipidemia - A PhaseⅠb/Ⅱ Randomized, Double-Blind, Placebo-Controlled Clinical Study
This is a randomized, double-blind, placebo- controlled phaseⅠb/Ⅱclinical study. Totally 108 subjects are planned to enrolled with 36 subjects in three low-dose groups (group 1, group 2 and group 3) and 72 subjects in three high-dose groups (group 4, group 5, and group 6).12 subjects with hyperlipidemia who received statin stable treatment for more than 28 days are enrolled in each low-dose group, randomly given SHR-1209 or placebo treatment at a ratio of 5:1. 24 subjects with hyperlipidemia who received statin stable treatment for more than 28 days are enrolled in each high-dose group, randomly given SHR-1209 or placebo treatment at a ratio of 5:1. The primary objective of this study is to evaluate the safety, tolerability, and efficacy of multiple subcutaneous injections of SHR-1209 in hyperlipidemia subjects treated with stabilized dose of statin. Groups detail as follows: 1. SHR-1209 dose 1 /placebo frequence 1 2. SHR-1209 dose 2 /placebo frequence 2 3. SHR-1209 dose 3 /placebo frequence 3 4. SHR-1209 dose 4 /placebo frequence 1 5. SHR-1209 dose 5 /placebo frequence 2 6. SHR-1209 dose 6 /placebo frequence 3
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00001154 -
Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
|
||
| Completed |
NCT02927184 -
Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
|
Phase 2 | |
| Completed |
NCT04640012 -
Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03213288 -
Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status
|
N/A | |
| Completed |
NCT00382564 -
Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease
|
N/A | |
| Recruiting |
NCT02979704 -
A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia
|
Phase 2/Phase 3 | |
| Completed |
NCT02569814 -
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
|
Phase 1 | |
| Completed |
NCT02428998 -
Safety for 24 Weeks Intake of Korean Red Ginseng in Adults
|
N/A | |
| Completed |
NCT02280590 -
Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia
|
Phase 4 | |
| Completed |
NCT01678183 -
Financial Incentives for Medication Adherence
|
N/A | |
| Completed |
NCT01426412 -
A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol
|
Phase 1 | |
| Completed |
NCT01694446 -
Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose
|
N/A | |
| Completed |
NCT01131832 -
Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols
|
Phase 4 | |
| Completed |
NCT00758303 -
A Study to Evaluate the Lipid Regulating Effects of TRIA-662
|
Phase 2/Phase 3 | |
| Completed |
NCT00534105 -
Lipid Metabolism in Gestational Diabetes
|
N/A | |
| Recruiting |
NCT00408824 -
Investigation of Genetic Risk of Metabolic Syndrome in Company Employee (NGK Study)
|
N/A | |
| Terminated |
NCT00299169 -
Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
|
Phase 4 | |
| Completed |
NCT00362206 -
Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin
|
Phase 3 | |
| Completed |
NCT00381992 -
Risk Assessment of Long-Haul Truck Drivers
|
N/A | |
| Completed |
NCT00414986 -
Using Learning Teams for Reflective Adaptation for Diabetes and Depression
|
N/A |