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New drug Kylo-11 aims to tackle stubborn heart disease risk factor

NCT ID NCT07327840

Disease control Sponsor: Kylonova (Xiamen) Biopharma co., LTD. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests Kylo-11, an experimental drug, in 204 adults with heart disease and high levels of lipoprotein(a) – a genetic risk factor for heart attacks and strokes. Participants receive either Kylo-11 or a placebo injection for about a year. The main goal is to see if Kylo-11 safely lowers Lp(a) levels over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Kylo-11
What this could lead to
If it works, this could lead to a new treatment to lower high lipoprotein(a) levels, potentially reducing heart disease risk.
What could go wrong
This is an early phase 2 trial with only 204 people, so results may not confirm benefit. The drug may not lower Lp(a) enough or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 204 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atherosclerotic cardiovascular disease hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lipoprotein disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    59 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alliance Clinical - Los Angeles

    NOT_YET_RECRUITING

    Los Angeles, California, 90301, United States

  • Alliance Clinical - San Diego

    NOT_YET_RECRUITING

    San Diego, California, 92115, United States

  • Alliance Clinical Las Vegas Excel Clinical Research

    NOT_YET_RECRUITING

    Las Vegas, Nevada, 89109, United States

  • Arrow Clinical Trials LLC

    NOT_YET_RECRUITING

    Daytona Beach, Florida, 32117, United States

  • Beijing Anzhen Hospital

    RECRUITING

    Beijing, China

  • Beijing Chao-Yang Hospital, Capital Medical University

    RECRUITING

    Beijing, China

  • Care Access-Lake Charles, LA

    NOT_YET_RECRUITING

    Lake Charles, Louisiana, 70601, United States

  • Central Hospital Affiliated to Shandong First Medical University

    RECRUITING

    Jinan, China

  • Centricity Research - Columbus

    NOT_YET_RECRUITING

    Columbus, Georgia, 31904, United States

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

    RECRUITING

    Morehead City, North Carolina, 28557, United States

  • China-Japan Union Hospital of Jilin University

    NOT_YET_RECRUITING

    Changchun, China

  • Chongqing University Three Gorges Hospital

    RECRUITING

    Chongqing, China

  • Clinical Research of West Florida (CRWF) - Clearwater

    RECRUITING

    Clearwater, Florida, 33765, United States

  • Clinical Research of West Florida (CRWF) - Tampa

    RECRUITING

    Tampa, Florida, 33606, United States

  • Daqingshi People's Hospital

    RECRUITING

    Daqing, China

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

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30324, United States

  • Excel Medical Trials - Flourish Research

    NOT_YET_RECRUITING

    Boca Raton, Florida, 33434, United States

  • FOMAT - Comprehensive Cardiovascular Care-Santa Maria California

    NOT_YET_RECRUITING

    Santa Maria, California, 93454, United States

  • Family Research Centers - Hialeah

    RECRUITING

    Hialeah, Florida, 33012, United States

  • Family Research and Healthcare Center Inc.

    RECRUITING

    Doral, Florida, 33126, United States

  • Guangzhou First People's Hospital

    NOT_YET_RECRUITING

    Guangzhou, China

  • Hainan Third People's Hospital

    RECRUITING

    Sanya, China

  • Jacksonville Center for Clinical Research

    RECRUITING

    Jacksonville, Florida, 32216, United States

  • Lishui Central Hospital

    RECRUITING

    Lishui, China

  • Luoyang Third People's Hospital

    RECRUITING

    Luoyang, China

  • Nanchang People's Hospital

    RECRUITING

    Nanchang, China

  • Nanyang Medical College First Affiliated Hospital

    RECRUITING

    Nanyang, China

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • People's Hospital of Zhengzhou

    RECRUITING

    Zhengzhou, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, China

  • Shaanxi Provincial People's Hospital

    RECRUITING

    Xi'an, China

  • Shanghai Putuo District Central Hospital

    NOT_YET_RECRUITING

    Shanghai, China

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

    NOT_YET_RECRUITING

    Chengdu, China

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

    RECRUITING

    Guangzhou, China

  • TEDA International Cardiovascular Hospital

    RECRUITING

    Tianjin, China

  • The Affiliated Hospital of Southwest Medical University

    NOT_YET_RECRUITING

    Luzhou, China

  • The Affiliated Hospital of Xuzhou Medical College

    RECRUITING

    Xuzhou, China

  • The First Affiliated Hospital of Baotou Medical College

    RECRUITING

    Baotou, China

  • The First Affiliated Hospital of Dali University

    RECRUITING

    Dali, China

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

    RECRUITING

    Luoyang, China

  • The First Affiliated Hospital of Ningbo University

    RECRUITING

    Ningbo, China

  • The First Affiliated Hospital of University of South China

    RECRUITING

    Hengyang, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    NOT_YET_RECRUITING

    Xi'an, China

  • The First Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, China

  • The First Hospital of Jilin University

    RECRUITING

    Jilin City, China

  • The First Hospital of Qiqihar

    NOT_YET_RECRUITING

    Qiqihar, China

  • The First People's Hospital of Changde

    NOT_YET_RECRUITING

    Changde, China

  • The Fourth Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, China

  • The Second Affiliated Hospital of Chongqing Medical University

    NOT_YET_RECRUITING

    Chongqing, China

  • The Second Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, China

  • The Third Xiangya Hospital of Central South University

    NOT_YET_RECRUITING

    Changsha, China

  • Tianjin People's Hospital

    RECRUITING

    Tianjin, China

  • Tongji Medical College of Hust Tongji Hospital

    RECRUITING

    Wuhan, China

  • Universal Axon Clinical Research

    NOT_YET_RECRUITING

    Miami, Florida, 33166, United States

  • Xiamen Cardiovascular Hospital Xiamen University

    RECRUITING

    Xiamen, China

  • Yan'an University Xianyang Hospital

    RECRUITING

    Xianyang, China

  • Yuncheng Central Hospital of Shanxi Province

    RECRUITING

    Yuncheng, China

  • Zhongshan Hospital Fudan University, Qingpu Branch

    RECRUITING

    Shanghai, China

  • Zibo Central Hospital

    RECRUITING

    Zibo, China

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