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Lipoprotein DisorderPhase 2NCT07327840

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

A Phase 2 study of Lipoprotein Disorder, run by Kylonova (Xiamen) Biopharma co., LTD. at 59 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lipoprotein Disorder
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
204 participants
Where
59 sitesin 2 countries
Study dates
29 Oct 2025to 31 Aug 2028
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 80 years
  • Clinical diagnosis of atherosclerotic cardiovascular disease with elevated Lp(a)
  • Other inclusion criteria applied per protocol.

Who cannot join

  • 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.

Trial locations and contacts

59 sites in 2 countries.

59 sites in 2 countries

China43 sites

  • The First Affiliated Hospital of Baotou Medical College

    Baotou

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Anzhen Hospital

    Beijing

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing

  • China-Japan Union Hospital of Jilin University

    Changchun

  • The First People's Hospital of Changde

    Changde

  • The Third Xiangya Hospital of Central South University

    Changsha

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

    Chengdu

  • Chongqing University Three Gorges Hospital

    Chongqing

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing

  • The First Affiliated Hospital of Dali University

    Dali

  • Daqingshi People's Hospital

    Daqing

  • Guangzhou First People's Hospital

    Guangzhou

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

    Guangzhou

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin

  • The First Affiliated Hospital of University of South China

    Hengyang

  • The First Hospital of Jilin University

    Jilin City

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan

  • Qilu Hospital of Shandong University

    Jinan

  • Lishui Central Hospital

    Lishui

  • Luoyang Third People's Hospital

    Luoyang

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang

  • The Affiliated Hospital of Southwest Medical University

    Luzhou

  • Nanchang People's Hospital

    Nanchang

  • Nanyang Medical College First Affiliated Hospital

    Nanyang

  • The First Affiliated Hospital of Ningbo University

    Ningbo

  • The First Hospital of Qiqihar

    Qiqihar

  • Hainan Third People's Hospital

    Sanya

  • Shanghai Putuo District Central Hospital

    Shanghai

  • Zhongshan Hospital Fudan University, Qingpu Branch

    Shanghai

  • The First Hospital of Hebei Medical University

    Shijiazhuang

  • TEDA International Cardiovascular Hospital

    Tianjin

  • Tianjin People's Hospital

    Tianjin

  • Tongji Medical College of Hust Tongji Hospital

    Wuhan

  • Shaanxi Provincial People's Hospital

    Xi'an

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • Xiamen Cardiovascular Hospital Xiamen University

    Xiamen

  • Yan'an University Xianyang Hospital

    Xianyang

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou

  • Yuncheng Central Hospital of Shanxi Province

    Yuncheng

  • People's Hospital of Zhengzhou

    Zhengzhou

  • Zibo Central Hospital

    Zibo

Other trials in China

United States16 sites

  • Emory Healthcare-Emory Heart & Vascular Center - Executive Park

    Atlanta, Georgia, 30324

  • Excel Medical Trials - Flourish Research

    Boca Raton, Florida, 33434

  • Clinical Research of West Florida (CRWF) - Clearwater

    Clearwater, Florida, 33765

  • Centricity Research - Columbus

    Columbus, Georgia, 31904

  • Arrow Clinical Trials LLC

    Daytona Beach, Florida, 32117

  • Family Research and Healthcare Center Inc.

    Doral, Florida, 33126

  • Family Research Centers - Hialeah

    Hialeah, Florida, 33012

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Care Access-Lake Charles, LA

    Lake Charles, Louisiana, 70601

  • Alliance Clinical Las Vegas Excel Clinical Research

    Las Vegas, Nevada, 89109

  • Alliance Clinical - Los Angeles

    Los Angeles, California, 90301

  • Universal Axon Clinical Research

    Miami, Florida, 33166

  • Centricity Research d/b/a Lucas Research, Inc.

    Morehead City, North Carolina, 28557

  • Alliance Clinical - San Diego

    San Diego, California, 92115

  • FOMAT - Comprehensive Cardiovascular Care-Santa Maria California

    Santa Maria, California, 93454

  • Clinical Research of West Florida (CRWF) - Tampa

    Tampa, Florida, 33606

Other trials in United States

About this study

Official title: 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).

Being tested
Kylo-11 or matched placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kylo-11 or matched placeboDrug

    Administered subcutaneously

Study groups in NCT07327840
Study groupRoleWhat they receive
Cohort 1ExperimentalKylo-11 dose 1 or matched placebo will be administered subcutaneously
Receives: Drug: Kylo-11 or matched placebo
Cohort 2ExperimentalKylo-11 dose 2 or matched placebo will be administered subcutaneously
Receives: Drug: Kylo-11 or matched placebo
Cohort 3ExperimentalKylo-11 dose 3 or matched placebo will be administered subcutaneously
Receives: Drug: Kylo-11 or matched placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Weeks 8~26

Secondary outcomes (2)

  1. 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.

    Measured: Baseline, Weeks 38~52

  2. 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.

    Measured: Week 26 and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study start29 Oct 2025
  3. Primary completion30 Sep 2026
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
204 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07327840
Sponsor's protocol ID
Kylo-11-II-C01
Status last verified
Oct 2026
First submitted
25 Dec 2025
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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