Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)
ConditionLipoprotein Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKylonova (Xiamen) Biopharma co., LTD.
About this trial
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 criteria
Qualifiers
Age 18 to 80 years
Clinical diagnosis of atherosclerotic cardiovascular disease with elevated Lp(a)
Other inclusion criteria applied per protocol.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Kylo-11 or matched placebo
Treatment groups
204 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov