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

This is a Phase 2 study testing a drug called Kylo-11 for people with atherosclerotic cardiovascular disease (ASCVD), a condition where plaque builds up in your arteries, and high levels of Lp(a) (lipoprotein(a)), a type of fat and protein in your blood that can increase heart disease risk. The study will compare Kylo-11, given as a shot under the skin, to a placebo (an inactive substance). We're looking to see how much Kylo-11 can change your Lp(a) levels over 8 to 26 weeks. You might be able to join if you are between 18 and 80 years old, have ASCVD, and elevated Lp(a). The study is currently recruiting about 204 participants.

Study design
This is a Phase 2, randomized, double-blind, placebo-controlled study involving about 204 participants. It aims to find the right dose of Kylo-11.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement of Lp(a) levels will be taken up to Week 26.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07327840

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

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Kylonova (Xiamen) Biopharma co., LTD.
~204 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Kylo-11 or matched placebo

At a glance

Recruiting sites
39 of 59 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent change from baseline in time-averaged Lp(a) over Weeks 8~26
Measured over Baseline, Weeks 8~26

Conditions

Lipoprotein Disorder

Explore related trials

AtherosclerosisLipoprotein DisorderApolipoprotein(a)

Where it's being run

59 sites across 8 states
China42
Florida8
California3
Georgia2
Louisiana1
Nevada1
North Carolina1
Beijing Municipality1

Who to contact

Qinsheng Zhang
[email protected]
+86-18936916318
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18 to 80 years
Clinical diagnosis of atherosclerotic cardiovascular disease with elevated Lp(a)

Exclusion

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)

What this trial measures

  • Percent change from baseline in time-averaged Lp(a) over Weeks 8~26Baseline, 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.