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New drug Kylo-12 enters first human safety trial for high cholesterol fats

NCT ID NCT06783881

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study tests a new drug called Kylo-12 in 50 healthy volunteers to see if it is safe and how the body processes it. The drug aims to lower high triglycerides, a type of fat in the blood linked to heart problems. Participants receive either a single shot of Kylo-12 or a placebo, and researchers monitor for side effects and measure drug levels in the blood.

What this could mean

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

Active substance
Kylo-12
What this could lead to
If successful, this could lead to a new treatment option for people with high triglycerides, a condition that raises heart disease risk.
What could go wrong
This is a very early Phase 1 trial in only 50 healthy people, so it is not yet known if Kylo-12 works or is safe long-term. Side effects are possible.

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

About 50 people

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

Started

Mar 2025

Expected to finish

Aug 2026

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 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 TG level; * 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.

hypertriglyceridemia

As listed by the trial registrant

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

Hypertriglyceridemia

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.