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

NCT07327840

RecruitingPhase 2

Sponsor: Kylonova (Xiamen) Biopharma co., LTD.

Conditions: Lipoprotein Disorder

Interventions: Kylo-11 or matched placebo

Countries: United States, China

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (59)
  • Los Angeles, California, United States
  • San Diego, California, United States
  • Santa Maria, California, United States
  • Boca Raton, Florida, United States
  • Clearwater, Florida, United States
  • Daytona Beach, Florida, United States
  • Doral, Florida, United States
  • Hialeah, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Columbus, Georgia, United States
  • Lake Charles, Louisiana, United States
  • Las Vegas, Nevada, United States
  • Morehead City, North Carolina, United States
  • Beijing, Beijing Municipality, China
  • Baotou, China
  • Beijing, China
  • Beijing, China
  • Changchun, China
  • Changde, China
  • Changsha, China
  • Chengdu, China
  • Chongqing, China
  • Chongqing, China
  • Dali, China
  • Daqing, China
  • Guangzhou, China
  • Guangzhou, China
  • + 29 more on CT.gov