Kylo-11 treatment for people with atherosclerotic cardiovascular disease and high 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)

This phase 2, randomized, double-blind test will try subcutaneous Kylo-11 versus placebo in adults with ASCVD and elevated Lp(a) to see if it lowers Lp(a) and is safe.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Kylonova (Xiamen) Biopharma co., LTD. (Industry-sponsored)
• Locations: 43 sites (Beijing, Beijing Municipality and 42 other locations)
• Trial ID: NCT07327840 on ClinicalTrials.gov

What this trial studies

This is a multicenter, double-blind, randomized, placebo-controlled, dose-finding phase 2 trial of subcutaneous Kylo-11 in adults with established atherosclerotic cardiovascular disease and elevated Lp(a). Participants are randomized to Kylo-11 or matched placebo and followed for safety and lipid biomarker responses, including changes in Lp(a). Key exclusions include moderate-to-severe heart failure (NYHA III–IV or LVEF <30%), uncontrolled hypertension or arrhythmias, and recent malignancy. The sponsor is Kylonova (Xiamen) Biopharma and enrollment occurs at several sites in China, including major cardiac centers in Beijing and Baotou.

Who should consider this trial

Good fit: Adults aged 18–80 with established atherosclerotic cardiovascular disease and elevated Lp(a) who meet the full protocol criteria are the intended participants.

Not a fit: People with NYHA class III–IV heart failure, LVEF below 30%, uncontrolled blood pressure or arrhythmias, or recent malignancy are unlikely to be eligible and may not benefit from participation.

Why it matters

Potential benefit: If successful, Kylo-11 could substantially lower Lp(a) and potentially reduce future cardiovascular risk in people with ASCVD and high Lp(a).

How similar studies have performed: Other targeted Lp(a) therapies, including antisense and siRNA agents, have shown substantial Lp(a) reductions in clinical trials, so this approach has precedent.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 42 other locations

• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hospital of Baotou Medical College — Baotou, China (Recruiting)
• Beijing Anzhen Hospital — Beijing, China (Recruiting)
• Beijing Chao-Yang Hospital, Capital Medical University — Beijing, China (Recruiting)
• China-Japan Union Hospital of Jilin University — Changchun, China (Not_yet_recruiting)
• The First People's Hospital of Changde — Changde, China (Not_yet_recruiting)
• The Third Xiangya Hospital of Central South University — Changsha, China (Not_yet_recruiting)
• Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital — Chengdu, China (Not_yet_recruiting)
• Chongqing University Three Gorges Hospital — Chongqing, China (Recruiting)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, China (Not_yet_recruiting)
• The First Affiliated Hospital of Dali University — Dali, China (Recruiting)
• Daqingshi People's Hospital — Daqing, China (Recruiting)
• Guangzhou First People's Hospital — Guangzhou, China (Not_yet_recruiting)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, China (Recruiting)
• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, China (Recruiting)
• The Fourth Affiliated Hospital of Harbin Medical University — Harbin, China (Recruiting)
• The First Affiliated Hospital of University of South China — Hengyang, China (Recruiting)
• The First Hospital of Jilin University — Jilin, China (Recruiting)
• Central Hospital Affiliated to Shandong First Medical University — Jinan, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, China (Recruiting)
• Lishui Central Hospital — Lishui, China (Recruiting)
• Luoyang Third People's Hospital — Luoyang, China (Recruiting)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, China (Recruiting)
• The Affiliated Hospital of Southwest Medical University — Luzhou, China (Not_yet_recruiting)
• Nanchang People's Hospital — Nanchang, China (Recruiting)
• Nanyang Medical College First Affiliated Hospital — Nanyang, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, China (Recruiting)
• The First Hospital of Qiqihar — Qiqihar, China (Not_yet_recruiting)
• Hainan Third People's Hospital — Sanya, China (Recruiting)
• Shanghai Putuo District Central Hospital — Shanghai, China (Not_yet_recruiting)
• Zhongshan Hospital Fudan University, Qingpu Branch — Shanghai, China (Recruiting)
• The First Hospital of Hebei Medical University — Shijiazhuang, China (Recruiting)
• TEDA International Cardiovascular Hospital — Tianjin, China (Recruiting)
• Tianjin People's Hospital — Tianjin, China (Recruiting)
• Tongji Medical College of Hust Tongji Hospital — Wuhan, China (Recruiting)
• Shaanxi Provincial People's Hospital — Xi'an, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Not_yet_recruiting)
• Xiamen Cardiovascular Hospital Xiamen University — Xiamen, China (Recruiting)
• Yan'an University Xianyang Hospital — Xianyang, China (Recruiting)
• The Affiliated Hospital of Xuzhou Medical College — Xuzhou, China (Recruiting)
• Yuncheng Central Hospital of Shanxi Province — Yuncheng, China (Recruiting)
• People's Hospital of Zhengzhou — Zhengzhou, China (Recruiting)
• Zibo Central Hospital — Zibo, China (Recruiting)

Study contacts

• Study coordinator: Qinsheng Zhang

Conditions Lipoprotein Disorder