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

Conditions

• Lipoprotein Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Kylo-11 or matched placebo — DRUG
  Administered subcutaneously

Study Details

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).

Key Dates

Start date

Oct 29, 2025

Status verified

Jun 2026

Primary completion

Feb 28, 2027

Completion

Aug 31, 2028

Study Design

Enrollment

204 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1
  Kylo-11 dose 1 or matched placebo will be administered subcutaneously
• Experimental: Cohort 2
  Kylo-11 dose 2 or matched placebo will be administered subcutaneously
• Experimental: Cohort 3
  Kylo-11 dose 3 or matched placebo will be administered subcutaneously

Primary Outcome Measure

Percent change from baseline in time-averaged Lp(a) over Weeks 8~26 [ Time Frame: Baseline, Weeks 8~26 ]

Central Contacts

• Qinsheng Zhang
  +86-18936916318
  [email protected]

Locations (16)

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