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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-29

Study Completion Date

2028-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Lipoprotein Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

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

Group Type EXPERIMENTAL

Kylo-11 or matched placebo

Intervention Type DRUG

Administered subcutaneously

Cohort 2

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

Group Type EXPERIMENTAL

Kylo-11 or matched placebo

Intervention Type DRUG

Administered subcutaneously

Cohort 3

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

Group Type EXPERIMENTAL

Kylo-11 or matched placebo

Intervention Type DRUG

Administered subcutaneously

Interventions

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Kylo-11 or matched placebo

Administered subcutaneously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 80 years
* Clinical diagnosis of atherosclerotic cardiovascular disease with elevated Lp(a)

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING