Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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 | |
| Alliance Clinical - San Diego | San Diego | California | |
| FOMAT - Comprehensive Cardiovascular Care-Santa Maria California | Santa Maria | California | |
| Excel Medical Trials - Flourish Research | Boca Raton | Florida | |
| Clinical Research of West Florida (CRWF) - Clearwater | Clearwater | Florida | |
| Arrow Clinical Trials LLC | Daytona Beach | Florida | |
| Family Research and Healthcare Center Inc. | Doral | Florida | |
| Family Research Centers - Hialeah | Hialeah | Florida | |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | |
| Universal Axon Clinical Research | Miami | Florida | |
| Clinical Research of West Florida (CRWF) - Tampa | Tampa | Florida | |
| Emory Healthcare-Emory Heart & Vascular Center - Executive Park | Atlanta | Georgia | |
| Centricity Research - Columbus | Columbus | Georgia | |
| Care Access-Lake Charles, LA | Lake Charles | Louisiana | |
| Alliance Clinical Las Vegas Excel Clinical Research | Las Vegas | Nevada | |
| Centricity Research d/b/a Lucas Research, Inc. | Morehead City | North Carolina | |
| Peking University First Hospital | Beijing | Beijing Municipality | |
| The First Affiliated Hospital of Baotou Medical College | Baotou | China | |
| Beijing Anzhen Hospital | Beijing | China | |
| Beijing Chao-Yang Hospital, Capital Medical University | Beijing | China | |
| China-Japan Union Hospital of Jilin University | Changchun | China | |
| The First People's Hospital of Changde | Changde | China | |
| The Third Xiangya Hospital of Central South University | Changsha | China | |
| Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital | Chengdu | China | |
| Chongqing University Three Gorges Hospital | Chongqing | China | |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | China | |
| The First Affiliated Hospital of Dali University | Dali | China | |
| Daqingshi People's Hospital | Daqing | China | |
| Guangzhou First People's Hospital | Guangzhou | China | |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | China | |
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | China | |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | China | |
| The First Affiliated Hospital of University of South China | Hengyang | China | |
| The First Hospital of Jilin University | Jilin City | China | |
| Central Hospital Affiliated to Shandong First Medical University | Jinan | China | |
| Qilu Hospital of Shandong University | Jinan | China | |
| Lishui Central Hospital | Lishui | China | |
| Luoyang Third People's Hospital | Luoyang | China | |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | China | |
| The Affiliated Hospital of Southwest Medical University | Luzhou | China |
+ 19 more sites — see the full list on the official registry below.
Other trials for the same condition
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 Japan