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

RecruitingPhase 2

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)

Who can join

Ages 18 to 80 · All sexes

Full eligibility criteria
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.

About the study

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).

What is being tested

Sponsor: Kylonova (Xiamen) Biopharma co., LTD. · Participants: 204 · Started: Oct 29, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07327840

Locations in the U.S.

CaliforniaAlliance Clinical - Los Angeles, Los Angeles (Not yet recruiting)
Alliance Clinical - San Diego, San Diego (Not yet recruiting)
FOMAT - Comprehensive Cardiovascular Care-Santa Maria California, Santa Maria (Not yet recruiting)
FloridaExcel Medical Trials - Flourish Research, Boca Raton (Not yet recruiting)
Clinical Research of West Florida (CRWF) - Clearwater, Clearwater
Arrow Clinical Trials LLC, Daytona Beach (Not yet recruiting)
Family Research and Healthcare Center Inc., Doral
Family Research Centers - Hialeah, Hialeah
Jacksonville Center for Clinical Research, Jacksonville
Universal Axon Clinical Research, Miami (Not yet recruiting)
Clinical Research of West Florida (CRWF) - Tampa, Tampa
GeorgiaEmory Healthcare-Emory Heart & Vascular Center - Executive Park, Atlanta (Not yet recruiting)
Centricity Research - Columbus, Columbus (Not yet recruiting)
LouisianaCare Access-Lake Charles, LA, Lake Charles (Not yet recruiting)
NevadaAlliance Clinical Las Vegas Excel Clinical Research, Las Vegas (Not yet recruiting)
North CarolinaCentricity Research d/b/a Lucas Research, Inc., Morehead City

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.