NCT07327840 Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)
| NCT ID | NCT07327840 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Kylonova (Xiamen) Biopharma co., LTD. |
| Condition | Lipoprotein Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2025-10-29 |
| Primary Completion | 2027-02-28 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 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