NCT07327840 Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)
| NCT ID | NCT07327840 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Kylonova (Xiamen) Biopharma co., LTD. |
| Condition | Lipoprotein Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2025-10-29 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 204 participants in total. It began in 2025-10-29 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07327840 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Lipoprotein Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07327840 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07327840 currently recruiting?
Yes, NCT07327840 is actively recruiting participants. Contact the research team at zhangqsh@hygieiapharma.com for enrollment information.
Where is the NCT07327840 trial being conducted?
This trial is being conducted at Los Angeles, United States, San Diego, United States, Santa Maria, United States, Boca Raton, United States and 11 additional locations.
Who is sponsoring the NCT07327840 clinical trial?
NCT07327840 is sponsored by Kylonova (Xiamen) Biopharma co., LTD.. The trial plans to enroll 204 participants.