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New drug Kylo-11 tested to lower hidden heart risk

NCT ID NCT06363851

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study tested a new drug called Kylo-11 in 71 healthy adults with high levels of Lp(a), a genetic risk factor for heart disease. The main goal was to check safety and how the drug moves through the body. Researchers gave single doses at different levels to see if it's safe and well-tolerated.

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 successful, this could lead to a new treatment to lower Lp(a) and reduce heart disease risk.
What could go wrong
This is a very early, small study in healthy volunteers, not patients. It only tests safety and dosing, not whether it actually prevents heart problems.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

71 people

The number who actually took part.

Started

May 2024

Finished

Dec 2025

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 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Men and women aged 18 to 55 years old, inclusive; * Body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive; * Protocol-defined elevated serum Lp(a) level: Lp(a) 75 \~ 200 nmol/L for Cohort 1-6; Lp(a) \>200 nmol/L for Cohort 7; * Female subjects must not be able to get pregnant and male subjects must agree to adhere to contraception restrictions; * Willing to comply with protocol required visits and assessments, and provide written informed consent. Exclusion Criteria: * History or evidence of a clinically significant disorder, condition or disease; * Received an investigational drug, vaccine or device within 3 months before dosing; * History of evidence of malignant tumor or Gilbert syndrome; * Positive screen of Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection; * History of alcohol abuse within 12 months before dosing; * History of drug abuse within 3 months before screening; * History of blood donations or blood loss of 400 ml and more within 3 months before dosing; * History of stroke or myocardial infarction within 6 months before sceening; * Pregnant or breast-feeding women; * Other exclusion criteria applied per protocol.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder

As listed by the trial registrant

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

Cardiovascular diseases

Contacts and locations

Locations

  • Chengdu Xinhua Hospital

    Chengdu, Sichuan, 610000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.