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Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)
Sponsor: Kylonova (Xiamen) Biopharma co., LTD.
Summary
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).
Official title: A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy and Safety of Kylo-11 in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
204
Start Date
2025-10-29
Completion Date
2028-08-31
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
Kylo-11 or matched placebo
Administered subcutaneously
Locations (48)
Alliance Clinical - Los Angeles
Los Angeles, California, United States
FOMAT - Clinicas mi Salud
Oxnard, California, United States
Alliance Clinical - San Diego
San Diego, California, United States
FOMAT - Comprehensive Cardiovascular Care-Santa Maria California
Santa Maria, California, United States
Excel Medical Trials - Flourish Research
Boca Raton, Florida, United States
Clinical Research of West Florida (CRWF) - Clearwater
Clearwater, Florida, United States
Arrow Clinical Trials LLC
Daytona Beach, Florida, United States
Family Research and Healthcare Center Inc.
Doral, Florida, United States
Family Research Centers - Hialeah
Hialeah, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Universal Axon Clinical Research
Miami, Florida, United States
Clinical Research of West Florida (CRWF) - Tampa
Tampa, Florida, United States
Flourish Orlando - Flourish Research
Winter Park, Florida, United States
Emory Healthcare-Emory Heart & Vascular Center - Executive Park
Atlanta, Georgia, United States
Centricity Research - Columbus
Columbus, Georgia, United States
Care Access-Lake Charles, LA
Lake Charles, Louisiana, United States
Alliance Clinical Las Vegas Excel Clinical Research
Las Vegas, Nevada, United States
Centricity Research d/b/a Lucas Research, Inc.
Morehead City, North Carolina, United States
Peking University First Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Baotou Medical College
Baotou, China
Beijing Anzhen Hospital
Beijing, China
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
The First People's Hospital of Changde
Changde, China
Chongqing University Three Gorges Hospital
Chongqing, China
The First Affiliated Hospital of Dali University
Dali, China
Daqingshi People's Hospital
Daqing, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, China
The First Affiliated Hospital of University of South China
Hengyang, China
The First Hospital of Jilin University
Jilin City, China
Central Hospital Affiliated to Shandong First Medical University
Jinan, China
Lishui Central Hospital
Lishui, China
Luoyang Third People's Hospital
Luoyang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Nanyang Medical College First Affiliated Hospital
Nanyang, China
The First Affiliated Hospital of Ningbo University
Ningbo, China
Hainan Third People's Hospital
Sanya, China
Shanghai Putuo District Central Hospital
Shanghai, China
Zhongshan Hospital Fudan University, Qingpu Branch
Shanghai, China
The First Hospital of Hebei Medical University
Shijiazhuang, China
TEDA International Cardiovascular Hospital
Tianjin, China
Tianjin People's Hospital
Tianjin, China
Tongji Medical College of Hust Tongji Hospital
Wuhan, China
Shaanxi Provincial People's Hospital
Xi'an, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, China
Yuncheng Central Hospital of Shanxi Province
Yuncheng, China
Zibo Central Hospital
Zibo, China