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NCT Number: NCT07327840

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

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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Key information

Conditions

Lipoprotein Disorder

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University First Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kylo-11 or matched placebo

Drug

Administered subcutaneously

Primary outcomes

  1. Percent change from baseline in time-averaged Lp(a) over Weeks 8~26

    Time frame: 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.

Secondary outcomes

  1. Percent change from baseline in time-averaged Lp(a) over Weeks 38~52

    Time frame: Baseline, Weeks 38~52

    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.

  2. Proportion of participants achieving Lp(a) <125 nmol/L and <75 nmol/L at Week 26 and Week 52

    Time frame: Week 26 and Week 52

    For proportion of participants achieving Lp(a) <125 nmol/L and <75 nmol/L at Week 26 and Week 52, the number of responders in both the Kylo-11 arm and the placebo arm will be calculated separately.

Study contacts

Contact information is provided by the study sponsor or research team.

Qinsheng Zhang

CONTACT

[email protected]

+86-18936916318

Sponsors and collaborators

Lead sponsor

Kylonova (Xiamen) Biopharma co., LTD.

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy and Safety of Kylo-11 in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 8, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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