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)

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).

Study Overview

• Status: Recruiting
• Conditions: Lipoprotein Disorder
• Intervention / Treatment: Drug: Kylo-11 or matched placebo

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qinsheng Zhang; Phone Number: +86-18936916318; Email: zhangqsh@hygieiapharma.com

Study Locations

• China
  • Baotou, China
    • Recruiting
    • The First Affiliated Hospital of Baotou Medical College
    • Contact: Xin Zhang
  • Beijing, China
    • Recruiting
    • Beijing Anzhen Hospital
    • Contact: Yanwen Qin
  • Beijing, China
    • Recruiting
    • Beijing Chao-Yang Hospital, Capital Medical University
    • Contact: Hong Li
  • Changchun, China
    • Not yet recruiting
    • China-Japan Union Hospital of Jilin University
    • Contact: Yuquan He
  • Changde, China
    • Not yet recruiting
    • The First People's Hospital of Changde
    • Contact: Liangqing Ge
  • Changsha, China
    • Not yet recruiting
    • The Third Xiangya Hospital of Central South University
    • Contact: Weihong Jiang
  • Chengdu, China
    • Not yet recruiting
    • Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
    • Contact: Jianhong Tao
  • Chongqing, China
    • Recruiting
    • Chongqing University Three Gorges Hospital
    • Contact: Jiang Shao
  • Chongqing, China
    • Not yet recruiting
    • The Second Affiliated Hospital of Chongqing Medical University
    • Contact: Jing Huang
  • Dali, China
    • Recruiting
    • The First Affiliated Hospital of Dali University
    • Contact: Yu Dong
  • Daqing, China
    • Recruiting
    • Daqingshi People's Hospital
    • Contact: Shu Zhang
  • Guangzhou, China
    • Recruiting
    • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    • Contact: Jingfeng Wang
  • Guangzhou, China
    • Recruiting
    • The second Affiliated Hospital of Guangzhou Medical University
    • Contact: Shiming Liu
  • Guangzhou, China
    • Not yet recruiting
    • Guangzhou First People's Hospital
    • Contact: Jian Liu
  • Harbin, China
    • Recruiting
    • The Fourth Affiliated Hospital of Harbin Medical University
    • Contact: Zhifeng Cheng
  • Hengyang, China
    • Recruiting
    • The First Affiliated Hospital of University of South China
    • Contact: Jie Wu
  • Jilin, China
    • Recruiting
    • The First Hospital of Jilin University
    • Contact: Wei Zhao
  • Jinan, China
    • Recruiting
    • Qilu Hospital of Shandong University
    • Contact: Shujian Wei
  • Jinan, China
    • Recruiting
    • Central Hospital Affiliated to Shandong First Medical University
    • Contact: Xiaoling Dong
  • Lishui, China
    • Recruiting
    • Lishui Central Hospital
    • Contact: Lingchun Lv
  • Luoyang, China
    • Recruiting
    • The First Affiliated Hospital of Henan University of Science And Technology
    • Contact: Hongwei Jiang
  • Luoyang, China
    • Recruiting
    • Luoyang Third People's Hospital
    • Contact: Lipeng Li
  • Luzhou, China
    • Not yet recruiting
    • The Affiliated Hospital of Southwest Medical University
    • Contact: Zhongcai Fan
  • Nanchang, China
    • Recruiting
    • Nanchang People's Hospital
    • Contact: Zhaohui Pei
  • Nanyang, China
    • Recruiting
    • Nanyang Medical College First Affiliated Hospital
    • Contact: Dexue Liu
  • Ningbo, China
    • Recruiting
    • The First Affiliated Hospital Of Ningbo University
    • Contact: Weiping Du
  • Qiqihar, China
    • Not yet recruiting
    • The First Hospital of Qiqihar
    • Contact: Jing Fu
  • Sanya, China
    • Recruiting
    • Hainan Third People's Hospital
    • Contact: Ling Lin
  • Shanghai, China
    • Not yet recruiting
    • Shanghai Putuo District Central Hospital
    • Contact: Zongjun Liu
  • Shanghai, China
    • Recruiting
    • Zhongshan Hospital Fudan University, Qingpu Branch
    • Contact: Haibo Liu
  • Shijiazhuang, China
    • Recruiting
    • The First Hospital of Hebei Medical University
    • Contact: Chao Liu
  • Tianjin, China
    • Recruiting
    • Teda International Cardiovascular Hospital
    • Contact: Jian Zhang
  • Tianjin, China
    • Recruiting
    • Tianjin People's Hospital
    • Contact: Zhuhua Yao
  • Wuhan, China
    • Recruiting
    • Tongji Medical College of Hust Tongji Hospital
    • Contact: Daowen Wang
  • Xi'an, China
    • Not yet recruiting
    • The First Affiliated Hospital of Xi'an Jiaotong University
    • Contact: Zuyi Yuan
  • Xi'an, China
    • Recruiting
    • Shaanxi provincial people's hospital
    • Contact: Junkui Wang
  • Xiamen, China
    • Recruiting
    • Xiamen Cardiovascular Hospital Xiamen University
    • Contact: Cuilian Dai
  • Xianyang, China
    • Recruiting
    • Yan'an University Xianyang Hospital
    • Contact: Qiufang Lian
  • Xuzhou, China
    • Recruiting
    • The Affiliated Hospital of Xuzhou Medical College
    • Contact: Defeng Pan
  • Yuncheng, China
    • Recruiting
    • Yuncheng Central Hospital of Shanxi Province
    • Contact: Yanlin Qu
  • Zhengzhou, China
    • Recruiting
    • People's Hospital of Zhengzhou
    • Contact: Guoying Geng
  • Zibo, China
    • Recruiting
    • Zibo Central Hospital
    • Contact: Bo Yin
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Jianping Li
      • Principal Investigator: Jianping Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Kylo-11 dose 1 or matched placebo will be administered subcutaneously	Drug: Kylo-11 or matched placebo; Administered subcutaneously
Experimental: Cohort 2; Kylo-11 dose 2 or matched placebo will be administered subcutaneously	Drug: Kylo-11 or matched placebo; Administered subcutaneously
Experimental: Cohort 3; Kylo-11 dose 3 or matched placebo will be administered subcutaneously	Drug: Kylo-11 or matched placebo; Administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change from baseline in time-averaged Lp(a) over Weeks 38~52	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 38~52
Proportion of participants achieving Lp(a) <125 nmol/L and <75 nmol/L at Week 26 and Week 52	For proportion of participants achieving Lp(a) <125 nmol/L and <75 nmol/L at Week 26 and Week 52, the number of responders in both the Kylo-11 arm and the placebo arm will be calculated separately.	Week 26 and Week 52

Collaborators and Investigators

• Sponsor: Kylonova (Xiamen) Biopharma co., LTD.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: December 25, 2025
• First Submitted That Met QC Criteria: December 25, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Kylo-11-II-C01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No