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
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Kylonova (Xiamen) Biopharma co., LTD.
- Enrollment
- 204
- Locations
- 51
- Primary Endpoint
- Percent change from baseline in time-averaged Lp(a) over Weeks 8~26
Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Cohort 1
Kylo-11 dose 1 or matched placebo will be administered subcutaneously
Intervention: Kylo-11 or matched placebo (Drug)
Cohort 2
Kylo-11 dose 2 or matched placebo will be administered subcutaneously
Intervention: Kylo-11 or matched placebo (Drug)
Cohort 3
Kylo-11 dose 3 or matched placebo will be administered subcutaneously
Intervention: Kylo-11 or matched placebo (Drug)
Outcomes
Primary Outcomes
Percent change from baseline in time-averaged Lp(a) over Weeks 8~26
Time Frame: 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.
Secondary Outcomes
- Percent change from baseline in time-averaged Lp(a) over Weeks 38~52(Baseline, Weeks 38~52)
- Proportion of participants achieving Lp(a) <125 nmol/L and <75 nmol/L at Week 26 and Week 52(Week 26 and Week 52)