Lipoprotein Disorder
Conditions
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).
Interventions
DRUGKylo-11 or matched placebo
Administered subcutaneously
Sponsors
Kylonova (Xiamen) Biopharma co., LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from baseline in time-averaged Lp(a) over Weeks 38~52 | Baseline, Weeks 38~52 | 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. |
| Proportion of participants achieving Lp(a) <125 nmol/L and <75 nmol/L at Week 26 and Week 52 | Week 26 and Week 52 | For proportion of participants achieving Lp(a) \<125 nmol/L and \<75 nmol/L at Week 26 and Week 52, the number of responders in both the Kylo-11 arm and the placebo arm will be calculated separately. |
Countries
China, United States
Contacts
CONTACTQinsheng Zhang
Outcome results
None listed