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

Kylonova (Xiamen) Biopharma co., LTD.

Status and phase: Enrolling; Phase 2

Conditions: Lipoprotein Disorder

Treatments: Drug: Kylo-11 or matched placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07327840

Kylo-11-II-C01

Details and patient eligibility

About

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).

Enrollment: 204 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Kylo-11 dose 1 or matched placebo will be administered subcutaneously

Treatment:

Drug: Kylo-11 or matched placebo

Cohort 2

Experimental group

Description:

Kylo-11 dose 2 or matched placebo will be administered subcutaneously

Treatment:

Drug: Kylo-11 or matched placebo

Cohort 3

Experimental group

Description:

Kylo-11 dose 3 or matched placebo will be administered subcutaneously

Treatment:

Drug: Kylo-11 or matched placebo