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

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

Recruiting
18-80 years
All
Phase 2

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Overview

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

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.

Study details
    Lipoprotein Disorder

NCT07327840

Kylonova (Xiamen) Biopharma co., LTD.

1 February 2026

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