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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Lipoprotein Disorder

In brief

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).

Key facts

Study ID

NCT07327840

Run by

Kylonova (Xiamen) Biopharma co., LTD.

People needed

204

Starts

2025-10-29

Expected to finish

2028-08-31

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 80 years
• Clinical diagnosis of atherosclerotic cardiovascular disease with elevated Lp(a)
• Other inclusion criteria applied per protocol.

You may not qualify if…

• 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.

Where it is running

• The First Affiliated Hospital of University of South China — Hengyang, China (enrolling)
• Nanchang People's Hospital — Nanchang, China (enrolling)
• The First Affiliated Hospital of Dali University — Dali, China (enrolling)
• The Fourth Affiliated Hospital of Harbin Medical University — Harbin, China (enrolling)
• Lishui Central Hospital — Lishui, China (enrolling)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, China (enrolling)
• Family Research Centers - Hialeah — Hialeah, Florida, United States (enrolling)
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (enrolling)
• Daqingshi People's Hospital — Daqing, China (enrolling)
• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, China (enrolling)
• Central Hospital Affiliated to Shandong First Medical University — Jinan, China (enrolling)
• Qilu Hospital of Shandong University — Jinan, China (enrolling)
• Family Research and Healthcare Center Inc. — Doral, Florida, United States (enrolling)
• Luoyang Third People's Hospital — Luoyang, China (enrolling)
• Centricity Research d/b/a Lucas Research, Inc. — Morehead City, North Carolina, United States (enrolling)
• Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Baotou Medical College — Baotou, China (enrolling)
• Beijing Anzhen Hospital — Beijing, China (enrolling)
• Beijing Chao-Yang Hospital, Capital Medical University — Beijing, China (enrolling)
• Clinical Research of West Florida (CRWF) - Clearwater — Clearwater, Florida, United States (enrolling)
• Clinical Research of West Florida (CRWF) - Tampa — Tampa, Florida, United States (enrolling)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, China (enrolling)
• The First Hospital of Jilin University — Jilin City, China (enrolling)
• Chongqing University Three Gorges Hospital — Chongqing, China (enrolling)
• Nanyang Medical College First Affiliated Hospital — Nanyang, China (enrolling)

Full record on ClinicalTrials.gov

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