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)
1 other identifier
interventional
204
1 country
43
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2025
Typical duration for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 29, 2025
CompletedFirst Submitted
Initial submission to the registry
December 25, 2025
CompletedFirst Posted
Study publicly available on registry
January 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
March 23, 2026
March 1, 2026
1.3 years
December 25, 2025
March 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change from baseline in time-averaged Lp(a) over Weeks 8~26
A MMRM including terms of treatment arm, stratification factors, scheduled visit and the interaction of treatment arm with scheduled visit will be used to estimate the percent change from baseline in time-averaged Lp(a) over Weeks 8\~26. The least squares means (LS means) by treatment arm and the treatment difference (Kylo-11 - placebo) based on the model will be summarized.
Baseline, Weeks 8~26
Secondary Outcomes (2)
Percent change from baseline in time-averaged Lp(a) over Weeks 38~52
Baseline, Weeks 38~52
Proportion of participants achieving Lp(a) <125 nmol/L and <75 nmol/L at Week 26 and Week 52
Week 26 and Week 52
Study Arms (3)
Cohort 1
EXPERIMENTALKylo-11 dose 1 or matched placebo will be administered subcutaneously
Cohort 2
EXPERIMENTALKylo-11 dose 2 or matched placebo will be administered subcutaneously
Cohort 3
EXPERIMENTALKylo-11 dose 3 or matched placebo will be administered subcutaneously
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 to 80 years
- Clinical diagnosis of atherosclerotic cardiovascular disease with elevated Lp(a)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
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, 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 25, 2025
First Posted
January 8, 2026
Study Start
October 29, 2025
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
August 31, 2028
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share