Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)
Purpose
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).
Condition
- Lipoprotein Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Clinical Research of West Florida (CRWF) - Clearwater
Clearwater, Florida 33765
Clearwater, Florida 33765
Contact:
Leonard Dunn
Leonard Dunn
Family Research and Healthcare Center Inc.
Doral, Florida 33126
Doral, Florida 33126
Contact:
Tomas Iglesias
Tomas Iglesias
Family Research Centers - Hialeah
Hialeah, Florida 33012
Hialeah, Florida 33012
Contact:
Tomas Iglesias
Tomas Iglesias
Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
Jacksonville, Florida 32216
Contact:
Michael J Koren
Michael J Koren
Clinical Research of West Florida (CRWF) - Tampa
Tampa, Florida 33606
Tampa, Florida 33606
Contact:
Lon Lynn
Lon Lynn
Centricity Research d/b/a Lucas Research, Inc.
Morehead City, North Carolina 28557
Morehead City, North Carolina 28557
Contact:
Kathryn Lucas
Kathryn Lucas
More Details
- Status
- Recruiting
- Sponsor
- Kylonova (Xiamen) Biopharma co., LTD.