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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
- Kylo-11 or matched placebo (drug)
Sponsor: Kylonova (Xiamen) Biopharma co., LTD. · Participants: 204 · Started: Oct 29, 2025
Contact the study team
- Qinsheng Zhang · Phone: +86-18936916318
Official record on ClinicalTrials.gov — NCT07327840
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.