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

2026-06-25

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

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 (59)

Facility	City	Region	Status
Alliance Clinical - Los Angeles	Los Angeles	California	Not Yet Recruiting
Alliance Clinical - San Diego	San Diego	California	Not Yet Recruiting
FOMAT - Comprehensive Cardiovascular Care-Santa Maria California	Santa Maria	California	Not Yet Recruiting
Excel Medical Trials - Flourish Research	Boca Raton	Florida	Not Yet Recruiting
Clinical Research of West Florida (CRWF) - Clearwater	Clearwater	Florida	Recruiting
Arrow Clinical Trials LLC	Daytona Beach	Florida	Not Yet Recruiting
Family Research and Healthcare Center Inc.	Doral	Florida	Recruiting
Family Research Centers - Hialeah	Hialeah	Florida	Recruiting
Jacksonville Center for Clinical Research	Jacksonville	Florida	Recruiting
Universal Axon Clinical Research	Miami	Florida	Not Yet Recruiting
Clinical Research of West Florida (CRWF) - Tampa	Tampa	Florida	Recruiting
Emory Healthcare-Emory Heart & Vascular Center - Executive Park	Atlanta	Georgia	Not Yet Recruiting
Centricity Research - Columbus	Columbus	Georgia	Not Yet Recruiting
Care Access-Lake Charles, LA	Lake Charles	Louisiana	Not Yet Recruiting
Alliance Clinical Las Vegas Excel Clinical Research	Las Vegas	Nevada	Not Yet Recruiting
Centricity Research d/b/a Lucas Research, Inc.	Morehead City	North Carolina	Recruiting
Peking University First Hospital	Beijing	Beijing Municipality	Recruiting
The First Affiliated Hospital of Baotou Medical College	Baotou	China	Recruiting
Beijing Anzhen Hospital	Beijing	China	Recruiting
Beijing Chao-Yang Hospital, Capital Medical University	Beijing	China	Recruiting
China-Japan Union Hospital of Jilin University	Changchun	China	Not Yet Recruiting
The First People's Hospital of Changde	Changde	China	Not Yet Recruiting
The Third Xiangya Hospital of Central South University	Changsha	China	Not Yet Recruiting
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital	Chengdu	China	Not Yet Recruiting
Chongqing University Three Gorges Hospital	Chongqing	China	Recruiting
The Second Affiliated Hospital of Chongqing Medical University	Chongqing	China	Not Yet Recruiting
The First Affiliated Hospital of Dali University	Dali	China	Recruiting
Daqingshi People's Hospital	Daqing	China	Recruiting
Guangzhou First People's Hospital	Guangzhou	China	Not Yet Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	China	Recruiting
The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	China	Recruiting
The Fourth Affiliated Hospital of Harbin Medical University	Harbin	China	Recruiting
The First Affiliated Hospital of University of South China	Hengyang	China	Recruiting
The First Hospital of Jilin University	Jilin City	China	Recruiting
Central Hospital Affiliated to Shandong First Medical University	Jinan	China	Recruiting
Qilu Hospital of Shandong University	Jinan	China	Recruiting
Lishui Central Hospital	Lishui	China	Recruiting
Luoyang Third People's Hospital	Luoyang	China	Recruiting
The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	China	Recruiting
The Affiliated Hospital of Southwest Medical University	Luzhou	China	Not Yet Recruiting

+ 19 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

Study of Oral HRS-5346 in Adult Patients With Elevated Lipoprotein(a) and High Risk of Cardiovascular Events Starting soon

A Study of DII235 in Adults With Elevated Lipoprotein(a) Active, not recruiting

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