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Clinical Trials in China / NCT07327840
Active, not recruiting Phase 2

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

NCT07327840 · tracked via the Priya Life Science China tracker
Sponsor
Kylonova (Xiamen) Biopharma co., LTD
Phase
Phase 2
Started
2025-10-29
Last updated
2026-10-29

Condition(s) studied

Lipoprotein Disorder

Investigational drug(s) / intervention(s)

Kylo-11 or matched placebo

Kylo-11 or matched placebo: Administered subcutaneously

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Percent change from baseline in time-averaged Lp(a) over Weeks 8~26 — Baseline, Weeks 8~26
    A MMRM including terms of treatment arm, stratification factors, scheduled visit and the interaction of treatment arm with scheduled visit will be used to estimate the percent change from baseline in time-averaged Lp(a) over Weeks 8\~26. The least squares means (LS means) by treatment arm and the treatment difference (Kylo-11 - placebo) based on the model will be summarized.

Trial sites (48)

FacilityCityRegionStatus
Alliance Clinical - Los Angeles Los Angeles California
FOMAT - Clinicas mi Salud Oxnard California
Alliance Clinical - San Diego San Diego California
FOMAT - Comprehensive Cardiovascular Care-Santa Maria California Santa Maria California
Excel Medical Trials - Flourish Research Boca Raton Florida
Clinical Research of West Florida (CRWF) - Clearwater Clearwater Florida
Arrow Clinical Trials LLC Daytona Beach Florida
Family Research and Healthcare Center Inc. Doral Florida
Family Research Centers - Hialeah Hialeah Florida
Jacksonville Center for Clinical Research Jacksonville Florida
Universal Axon Clinical Research Miami Florida
Clinical Research of West Florida (CRWF) - Tampa Tampa Florida
Flourish Orlando - Flourish Research Winter Park Florida
Emory Healthcare-Emory Heart & Vascular Center - Executive Park Atlanta Georgia
Centricity Research - Columbus Columbus Georgia
Care Access-Lake Charles, LA Lake Charles Louisiana
Alliance Clinical Las Vegas Excel Clinical Research Las Vegas Nevada
Centricity Research d/b/a Lucas Research, Inc. Morehead City North Carolina
Peking University First Hospital Beijing Beijing Municipality
The First Affiliated Hospital of Baotou Medical College Baotou China
Beijing Anzhen Hospital Beijing China
Beijing Chao-Yang Hospital, Capital Medical University Beijing China
The First People's Hospital of Changde Changde China
Chongqing University Three Gorges Hospital Chongqing China
The First Affiliated Hospital of Dali University Dali China
Daqingshi People's Hospital Daqing China
The Second Affiliated Hospital of Guangzhou Medical University Guangzhou China
The Fourth Affiliated Hospital of Harbin Medical University Harbin China
The First Affiliated Hospital of University of South China Hengyang China
The First Hospital of Jilin University Jilin City China
Central Hospital Affiliated to Shandong First Medical University Jinan China
Lishui Central Hospital Lishui China
Luoyang Third People's Hospital Luoyang China
The First Affiliated Hospital of Henan University of Science and Technology Luoyang China
Nanyang Medical College First Affiliated Hospital Nanyang China
The First Affiliated Hospital of Ningbo University Ningbo China
Hainan Third People's Hospital Sanya China
Shanghai Putuo District Central Hospital Shanghai China
Zhongshan Hospital Fudan University, Qingpu Branch Shanghai China
The First Hospital of Hebei Medical University Shijiazhuang China

+ 8 more sites — see the full list on the official registry below.

More Kylonova (Xiamen) Biopharma co., LTD. trials in China

Single-ascending Dose Study of Kylo-12 in Healthy Subjects Active, not recruiting

Other trials for the same condition

Phase I Clinical Study Evaluating the Relative Bioavailability of Different Formulations of HRS-5346 in Healthy Participants Starting soon
A Study of HRS-5632 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events Active, not recruiting
A Study of DII235 in Adults With Elevated Lipoprotein(a) Active, not recruiting
Study of Oral HRS-5346 in Adult Patients With Elevated Lipoprotein(a) and High Risk of Cardiovascular Events Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07327840 on ClinicalTrials.gov ↗ ← All trials in China