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This is a phase 2, double-blind, randomized, placebo-controlled, multi-center, dose-finding study to evaluate the efficacy and safety of Kylo-11 administered subcutaneously compared to placebo in participants with ASCVD and elevated Lp(a).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Kylo-11 dose 1 or matched placebo will be administered subcutaneously |
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| Cohort 2 | Experimental | Kylo-11 dose 2 or matched placebo will be administered subcutaneously |
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| Cohort 3 | Experimental | Kylo-11 dose 3 or matched placebo will be administered subcutaneously |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kylo-11 or matched placebo | Drug | Administered subcutaneously |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in time-averaged Lp(a) over Weeks 8~26 | A MMRM including terms of treatment arm, stratification factors, scheduled visit and the interaction of treatment arm with scheduled visit will be used to estimate the percent change from baseline in time-averaged Lp(a) over Weeks 8~26. The least squares means (LS means) by treatment arm and the treatment difference (Kylo-11 - placebo) based on the model will be summarized. | Baseline, Weeks 8~26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in time-averaged Lp(a) over Weeks 38~52 | A MMRM including terms of treatment arm, stratification factors, scheduled visit and the interaction of treatment arm with scheduled visit will be used to estimate the percent change from baseline in time-averaged Lp(a) over Weeks 8~26. The least squares means (LS means) by treatment arm and the treatment difference (Kylo-11 - placebo) based on the model will be summarized. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qinsheng Zhang | Contact | +86-18936916318 | zhangqsh@hygieiapharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance Clinical - Los Angeles | Not yet recruiting | Los Angeles | California | 90301 | United States |
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| Baseline, Weeks 38~52 |
| Proportion of participants achieving Lp(a) <125 nmol/L and <75 nmol/L at Week 26 and Week 52 | For proportion of participants achieving Lp(a) <125 nmol/L and <75 nmol/L at Week 26 and Week 52, the number of responders in both the Kylo-11 arm and the placebo arm will be calculated separately. | Week 26 and Week 52 |
| Alliance Clinical - San Diego | Not yet recruiting | San Diego | California | 92115 | United States |
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| FOMAT - Comprehensive Cardiovascular Care-Santa Maria California | Not yet recruiting | Santa Maria | California | 93454 | United States |
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| Excel Medical Trials - Flourish Research | Not yet recruiting | Boca Raton | Florida | 33434 | United States |
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| Clinical Research of West Florida (CRWF) - Clearwater | Recruiting | Clearwater | Florida | 33765 | United States |
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| Arrow Clinical Trials LLC | Not yet recruiting | Daytona Beach | Florida | 32117 | United States |
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| Family Research and Healthcare Center Inc. | Recruiting | Doral | Florida | 33126 | United States |
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| Family Research Centers - Hialeah | Recruiting | Hialeah | Florida | 33012 | United States |
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| Jacksonville Center for Clinical Research | Recruiting | Jacksonville | Florida | 32216 | United States |
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| Universal Axon Clinical Research | Not yet recruiting | Miami | Florida | 33166 | United States |
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| Clinical Research of West Florida (CRWF) - Tampa | Recruiting | Tampa | Florida | 33606 | United States |
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| Emory Healthcare-Emory Heart & Vascular Center - Executive Park | Not yet recruiting | Atlanta | Georgia | 30324 | United States |
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| Centricity Research - Columbus | Not yet recruiting | Columbus | Georgia | 31904 | United States |
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| Care Access-Lake Charles, LA | Not yet recruiting | Lake Charles | Louisiana | 70601 | United States |
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| Alliance Clinical Las Vegas Excel Clinical Research | Not yet recruiting | Las Vegas | Nevada | 89109 | United States |
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| Centricity Research d/b/a Lucas Research, Inc. | Recruiting | Morehead City | North Carolina | 28557 | United States |
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| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| The First Affiliated Hospital of Baotou Medical College | Recruiting | Baotou | China |
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| Beijing Anzhen Hospital | Recruiting | Beijing | China |
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| Beijing Chao-Yang Hospital, Capital Medical University | Recruiting | Beijing | China |
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| China-Japan Union Hospital of Jilin University | Not yet recruiting | Changchun | China |
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| The First People's Hospital of Changde | Not yet recruiting | Changde | China |
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| The Third Xiangya Hospital of Central South University | Not yet recruiting | Changsha | China |
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| Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | China |
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| Chongqing University Three Gorges Hospital | Recruiting | Chongqing | China |
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| The Second Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | China |
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| The First Affiliated Hospital of Dali University | Recruiting | Dali | China |
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| Daqingshi People's Hospital | Recruiting | Daqing | China |
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| Guangzhou First People's Hospital | Not yet recruiting | Guangzhou | China |
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| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | China |
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| The Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | China |
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| The Fourth Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | China |
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| The First Affiliated Hospital of University of South China | Recruiting | Hengyang | China |
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| The First Hospital of Jilin University | Recruiting | Jilin City | China |
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| Central Hospital Affiliated to Shandong First Medical University | Recruiting | Jinan | China |
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| Qilu Hospital of Shandong University | Recruiting | Jinan | China |
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| Lishui Central Hospital | Recruiting | Lishui | China |
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| Luoyang Third People's Hospital | Recruiting | Luoyang | China |
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| The First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | China |
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| The Affiliated Hospital of Southwest Medical University | Not yet recruiting | Luzhou | China |
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| Nanchang People's Hospital | Recruiting | Nanchang | China |
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| Nanyang Medical College First Affiliated Hospital | Recruiting | Nanyang | China |
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| The First Affiliated Hospital of Ningbo University | Recruiting | Ningbo | China |
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| The First Hospital of Qiqihar | Not yet recruiting | Qiqihar | China |
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| Hainan Third People's Hospital | Recruiting | Sanya | China |
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| Shanghai Putuo District Central Hospital | Not yet recruiting | Shanghai | China |
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| Zhongshan Hospital Fudan University, Qingpu Branch | Recruiting | Shanghai | China |
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| The First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | China |
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| TEDA International Cardiovascular Hospital | Recruiting | Tianjin | China |
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| Tianjin People's Hospital | Recruiting | Tianjin | China |
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| Tongji Medical College of Hust Tongji Hospital | Recruiting | Wuhan | China |
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| Shaanxi Provincial People's Hospital | Recruiting | Xi'an | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | China |
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| Xiamen Cardiovascular Hospital Xiamen University | Recruiting | Xiamen | China |
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| Yan'an University Xianyang Hospital | Recruiting | Xianyang | China |
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| The Affiliated Hospital of Xuzhou Medical College | Recruiting | Xuzhou | China |
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| Yuncheng Central Hospital of Shanxi Province | Recruiting | Yuncheng | China |
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| People's Hospital of Zhengzhou | Recruiting | Zhengzhou | China |
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| Zibo Central Hospital | Recruiting | Zibo | China |
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