Actively Recruiting
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)
Led by Kylonova (Xiamen) Biopharma co., LTD. · Updated on 2026-03-23
204
Participants Needed
43
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Kylo-11, a drug administered under the skin, in adults with atherosclerotic cardiovascular disease (ASCVD) who also have elevated lipoprotein(a) levels. This phase 2 study is designed as a double-blind, randomized, placebo-controlled trial to find the right dose while assessing the drug's effects and safety. The study includes multiple groups receiving different doses of Kylo-11 or a matching placebo, all given by subcutaneous injection. Participants are randomly assigned to one of three dose groups or their corresponding placebo. The study will compare outcomes over several weeks to understand how Kylo-11 affects lipoprotein(a) levels. Participants will have their lipoprotein(a) levels measured at the start and over weeks 8 to 26 as the main outcome, with additional measurements through week 52. The study will monitor safety and effectiveness through regular visits and tests. The total participation time may extend up to the study's end date in August 2028, including follow-up assessments.
CONDITIONS
Brief Title
Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Clinical diagnosis of atherosclerotic cardiovascular disease with elevated Lp(a)
- Other inclusion criteria applied per protocol.
You will not qualify if you...
- Moderate to severe heart failure (NYHA Functional Classification III or IV during Screening) or left ventricular ejection fraction less than 30%
- Uncontrolled hypertension (systolic blood pressure 616;0 mmHg or diastolic blood pressure 610;0 mmHg)
- Uncontrolled cardiac arrhythmia in the past 3 months prior to randomization
- Any malignancy within 5 years prior to randomization except certain successfully treated cancers
- Other exclusion criteria applied per protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants receive subcutaneous doses of Kylo-11 or matched placebo to evaluate efficacy and safety.
Multiple visits during Weeks 0 to 26 for dosing and assessments
Duration - 26 weeks
Participants continue to be monitored for safety and efficacy after the treatment period ends.
Visits at Weeks 38 and 52 for outcome assessments
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 City, 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
Research Team
Q
Qinsheng Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here