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Kylo-11 in ASCVD and Elevated Lp(a)
NCT07327840Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Oct 2025
- Primary completion
- Sep 2026
- Countries
- 2
- Sponsor
- Kylonova Biopharma
- Modality
- Conjugated siRNA, Chemically Modified siRNA
- Drugs
- KYLO-11
- Conditions
- atherosclerotic cardiovascular disease (ASCVD)lipoprotein disorder
01
Overview
Phase 2, randomised, double-blind trial of KYLO-11 in atherosclerotic cardiovascular disease (ASCVD) and lipoprotein disorder (3 cohorts), sponsored by Kylonova Biopharma. Primary endpoint: Percent change from baseline in time-averaged Lp(a). Started Oct 2025; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Cohort 1
Kylo-11 dose 1 or matched placebo will be administered subcutaneously
Cohort 2
Kylo-11 dose 2 or matched placebo will be administered subcutaneously
Cohort 3
Kylo-11 dose 3 or matched placebo will be administered subcutaneously
03
Who it enrols
Adults aged 18-80 with ASCVD and elevated Lp(a), excluding those with severe heart failure, uncontrolled hypertension, uncontrolled arrhythmias, or recent malignancies.
04
Endpoints
Primary
Percent change from baseline in time-averaged Lp(a)
Secondary
Percent change from baseline in time-averaged Lp(a)
Proportion of participants achieving Lp(a) <125 nmol/L and <75 nmol/L
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