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Recruiting NCT07327840

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

Phase II Interventional Lipoprotein Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Kylo-11 or matched placebo.
Who it may be relevant to
Registry conditions: Lipoprotein Disorder. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

Overview

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).

Interventions

  • Drug Kylo-11 or matched placebo
    Administered subcutaneously

Primary outcome measures

  • Percent change from baseline in time-averaged Lp(a) over Weeks 8~26 [Time frame: Baseline, Weeks 8~26]
Secondary outcome measures (2)
  • Percent change from baseline in time-averaged Lp(a) over Weeks 38~52 [Time frame: Baseline, Weeks 38~52]
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 43 centers
  • Peking University First Hospital — Beijing
  • The First Affiliated Hospital of Baotou Medical College — Baotou
  • Beijing Anzhen Hospital — Beijing
  • Beijing Chao-Yang Hospital, Capital Medical University — Beijing
  • China-Japan Union Hospital of Jilin University — Changchun
  • The First People's Hospital of Changde — Changde
  • The Third Xiangya Hospital of Central South University — Changsha
  • Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital — Chengdu
  • … and 35 more centers
United States · 16 centers
  • Alliance Clinical - Los Angeles — Los Angeles
  • Alliance Clinical - San Diego — San Diego
  • FOMAT - Comprehensive Cardiovascular Care-Santa Maria California — Santa Maria
  • Excel Medical Trials - Flourish Research — Boca Raton
  • Clinical Research of West Florida (CRWF) - Clearwater — Clearwater
  • Arrow Clinical Trials LLC — Daytona Beach
  • Family Research and Healthcare Center Inc. — Doral
  • Family Research Centers - Hialeah — Hialeah
  • … and 8 more centers

Identifiers

NCT: NCT07327840 · Kylo-11-II-C01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗