Recruiting
Phase 2

Kylo-11

Sponsor:

Kylonova (Xiamen) Biopharma co., LTD.

Code:

NCT07327840

Conditions

Lipoprotein Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Kylo-11 or matched placebo

Study Details

Brief 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).

Conditions

Lipoprotein Disorder

Study ID

NCT07327840

Start date

Oct 29, 2025

Status verified date

Jun, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

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

experimental: Cohort 2

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

experimental: Cohort 3

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

Interventions

Kylo-11 or matched placebo

Administered subcutaneously

Primary outcome measure

  • Percent change from baseline in time-averaged Lp(a) over Weeks 8~26 [ Time Frame: Baseline, Weeks 8~26 ]

Central Contacts and Locations

Central contacts

Qinsheng Zhang

+86-18936916318zhangqsh@hygieiapharma.com

Locations

Clinical Research of West Florida (CRWF) - Clearwater

Recruiting

Clearwater, Florida, United States, 33765

Family Research and Healthcare Center Inc.

Recruiting

Doral, Florida, United States, 33126

Family Research Centers - Hialeah

Recruiting

Hialeah, Florida, United States, 33012

Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

Clinical Research of West Florida (CRWF) - Tampa

Recruiting

Tampa, Florida, United States, 33606

Centricity Research d/b/a Lucas Research, Inc.

Recruiting

Morehead City, North Carolina, United States, 28557

More Information

Sponsor

Kylonova (Xiamen) Biopharma co., LTD.

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kylonova (Xiamen) Biopharma co., LTD. on 2026-06-25.