RecruitingPhase 2NCT07327840

Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)

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)

Sponsor

Kylonova (Xiamen) Biopharma co., LTD.

Enrollment

204 participants

Start Date

Oct 29, 2025

Study Type

INTERVENTIONAL

Conditions

Lipoprotein Disorder

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).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Kylo-11 or matched placebo for people with lipoprotein disorder. The study is currently recruiting participants at 43 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKylo-11 or matched placebo

Administered subcutaneously

Locations(59)

Alliance Clinical - Los Angeles

Los Angeles, 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

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

China-Japan Union Hospital of Jilin University

Changchun, China

The First People's Hospital of Changde

Changde, China

The Third Xiangya Hospital of Central South University

Changsha, China

Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital

Chengdu, China

Chongqing University Three Gorges Hospital

Chongqing, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

The First Affiliated Hospital of Dali University

Dali, China

Daqingshi People's Hospital

Daqing, China

Guangzhou First People's Hospital

Guangzhou, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, 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

Qilu Hospital of Shandong 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

The Affiliated Hospital of Southwest Medical University

Luzhou, China

Nanchang People's Hospital

Nanchang, China

Nanyang Medical College First Affiliated Hospital

Nanyang, China

The First Affiliated Hospital of Ningbo University

Ningbo, China

The First Hospital of Qiqihar

Qiqihar, 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

Yan'an University Xianyang Hospital

Xianyang, China

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, China

Yuncheng Central Hospital of Shanxi Province

Yuncheng, China

People's Hospital of Zhengzhou

Zhengzhou, China

Zibo Central Hospital

Zibo, China

View Full Details on ClinicalTrials.gov

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NCT07327840

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