Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed for multi-center, double-blind, randomized, placebo-controlled phase III trial to evaluate the safety and tolerability of subcutaneous injection of IBI306 in hypercholesterolemia patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI306 | Experimental | IBI306 administered subcutaneously (SC) |
|
| Placebo | Placebo Comparator | administered subcutaneously (SC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI306 | Drug | Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12 | Baseline to week12 |
| Measure | Description | Time Frame |
|---|---|---|
| The percent of subjects with LDL-C reduction no less than 50% from baseline | Baseline to week24 | |
| The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L) | Baseline to week24 | |
Not provided
Inclusion criteria
Exclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37614541 | Derived | Qi L, Liu D, Qu Y, Chen B, Meng H, Zhu L, Li L, Wang S, Liu C, Zheng G, Lian Q, Yin G, Lv L, Lu D, Chen X, Xue F, An P, Li H, Deng H, Li L, Qian L, Huo Y. Tafolecimab in Chinese Patients With Hypercholesterolemia (CREDIT-4): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial. JACC Asia. 2023 Jul 11;3(4):636-645. doi: 10.1016/j.jacasi.2023.04.011. eCollection 2023 Aug. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24 |
|
| The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline |
| Baseline to week24 |
| D009750 |
| Nutritional and Metabolic Diseases |