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NCT07327840PHASE2Recruiting

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

Kylonova (Xiamen) Biopharma co., LTD.

Start Date

10/29/2025

Completion Date

8/31/2028

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 Criteria

Age Range: 18 years to 80 years

Inclusion Criteria: * Age 18 to 80 years * Clinical diagnosis of atherosclerotic cardiovascular disease with elevated Lp(a) * Other inclusion criteria applied per protocol. Exclusion Criteria: * Have moderate to severe heart failure (New York Heart Association \[NYHA\] Functional Classification III or IV during Screening) or last known left ventricular ejection fraction \<30% * Have uncontrolled hypertension (systolic blood pressure \[SBP\] ≥160 mmHg or diastolic blood pressure \[DBP\] ≥100 mmHg) * Have uncontrolled cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 3 months prior to randomization * Have had any malignancy within 5 years prior to randomization (except for non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma that has been successfully treated) * Other exclusion criteria applied per protocol.

Interventions

DRUG

Kylo-11 or matched placebo

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Conditions

Lipoprotein Disorder

Locations

Alliance Clinical - Los Angeles

Los Angeles, California 90301

United States

Alliance Clinical - San Diego

San Diego, California 92115

United States

FOMAT - Comprehensive Cardiovascular Care-Santa Maria California

Santa Maria, California 93454

United States

Excel Medical Trials - Flourish Research

Boca Raton, Florida 33434

United States

Clinical Research of West Florida (CRWF) - Clearwater

Clearwater, Florida 33765

United States

Arrow Clinical Trials LLC

Daytona Beach, Florida 32117

United States

Family Research and Healthcare Center Inc.

Doral, Florida 33126

United States

Family Research Centers - Hialeah

Hialeah, Florida 33012

United States

Jacksonville Center for Clinical Research

Jacksonville, Florida 32216

United States

Universal Axon Clinical Research

Miami, Florida 33166

United States

Clinical Research of West Florida (CRWF) - Tampa

Tampa, Florida 33606

United States

Emory Healthcare-Emory Heart & Vascular Center - Executive Park

Atlanta, Georgia 30324

United States

Centricity Research - Columbus

Columbus, Georgia 31904

United States

Care Access-Lake Charles, LA

Lake Charles, Louisiana 70601

United States

Alliance Clinical Las Vegas Excel Clinical Research

Las Vegas, Nevada 89109

United States

Centricity Research d/b/a Lucas Research, Inc.

Morehead City, North Carolina 28557

United States

Peking University First Hospital

Beijing, Beijing Municipality 100034

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