Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT07327840

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

Led by Kylonova (Xiamen) Biopharma co., LTD. · Updated on 2026-03-23

204

Participants Needed

43

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 80 years
  • Clinical diagnosis of atherosclerotic cardiovascular disease with elevated lipoprotein(a)
  • Other inclusion criteria applied per protocol.
Not Eligible

You will not qualify if you...

  • Moderate to severe heart failure (NYHA Functional Classification III or IV during Screening) or left ventricular ejection fraction <30%
  • Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)
  • Uncontrolled cardiac arrhythmia such as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia not controlled by medications in the past 3 months
  • 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 successfully treated)
  • Other exclusion criteria applied per protocol.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 43 locations

1

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

2

The First Affiliated Hospital of Baotou Medical College

Baotou, China

Actively Recruiting

3

Beijing Anzhen Hospital

Beijing, China

Actively Recruiting

4

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, China

Actively Recruiting

5

China-Japan Union Hospital of Jilin University

Changchun, China

Not Yet Recruiting

6

The First People's Hospital of Changde

Changde, China

Not Yet Recruiting

7

The Third Xiangya Hospital of Central South University

Changsha, China

Not Yet Recruiting

8

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

Chengdu, China

Not Yet Recruiting

9

Chongqing University Three Gorges Hospital

Chongqing, China

Actively Recruiting

10

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

Not Yet Recruiting

11

The First Affiliated Hospital of Dali University

Dali, China

Actively Recruiting

12

Daqingshi People's Hospital

Daqing, China

Actively Recruiting

13

Guangzhou First People's Hospital

Guangzhou, China

Not Yet Recruiting

14

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

Guangzhou, China

Actively Recruiting

15

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Actively Recruiting

16

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, China

Actively Recruiting

17

The First Affiliated Hospital of University of South China

Hengyang, China

Actively Recruiting

18

The First Hospital of Jilin University

Jilin, China

Actively Recruiting

19

Central Hospital Affiliated to Shandong First Medical University

Jinan, China

Actively Recruiting

20

Qilu Hospital of Shandong University

Jinan, China

Actively Recruiting

21

Lishui Central Hospital

Lishui, China

Actively Recruiting

22

Luoyang Third People's Hospital

Luoyang, China

Actively Recruiting

23

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

Actively Recruiting

24

The Affiliated Hospital of Southwest Medical University

Luzhou, China

Not Yet Recruiting

25

Nanchang People's Hospital

Nanchang, China

Actively Recruiting

26

Nanyang Medical College First Affiliated Hospital

Nanyang, China

Actively Recruiting

27

The First Affiliated Hospital of Ningbo University

Ningbo, China

Actively Recruiting

28

The First Hospital of Qiqihar

Qiqihar, China

Not Yet Recruiting

29

Hainan Third People's Hospital

Sanya, China

Actively Recruiting

30

Shanghai Putuo District Central Hospital

Shanghai, China

Not Yet Recruiting

31

Zhongshan Hospital Fudan University, Qingpu Branch

Shanghai, China

Actively Recruiting

32

The First Hospital of Hebei Medical University

Shijiazhuang, China

Actively Recruiting

33

TEDA International Cardiovascular Hospital

Tianjin, China

Actively Recruiting

34

Tianjin People's Hospital

Tianjin, China

Actively Recruiting

35

Tongji Medical College of Hust Tongji Hospital

Wuhan, China

Actively Recruiting

36

Shaanxi Provincial People's Hospital

Xi'an, China

Actively Recruiting

37

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Not Yet Recruiting

38

Xiamen Cardiovascular Hospital Xiamen University

Xiamen, China

Actively Recruiting

39

Yan'an University Xianyang Hospital

Xianyang, China

Actively Recruiting

40

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, China

Actively Recruiting

41

Yuncheng Central Hospital of Shanxi Province

Yuncheng, China

Actively Recruiting

42

People's Hospital of Zhengzhou

Zhengzhou, China

Actively Recruiting

43

Zibo Central Hospital

Zibo, China

Actively Recruiting

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Research Team

Q

Qinsheng Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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