RecruitingPhase 2NCT07327840
Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)
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)
Sponsor
Kylonova (Xiamen) Biopharma co., LTD.
Enrollment
204 participants
Start Date
Oct 29, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria2
- Age 18 to 80 years
- Clinical diagnosis of atherosclerotic cardiovascular disease with elevated Lp(a)
Exclusion Criteria4
- 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)
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Interventions
DRUGKylo-11 or matched placebo
Administered subcutaneously
Locations(43)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07327840