Phase 2 Double-Blind Study of Subcutaneous Kylo-11 in Adults with Atherosclerotic Cardiovascular Disease and High Lipoproteina

What this Trial Is About

Researchers are evaluating the drug Kylo-11 in adults with atherosclerotic cardiovascular disease ASCVD who also have elevated levels of lipoproteina, a condition related to cardiovascular risk. This phase 2, double-blind, randomized, placebo-controlled study aims to find the effective dose and assess the safety of Kylo-11 compared to a placebo in this population. Participants will receive one of three different doses of Kylo-11 or a matched placebo, all administered by injection under the skin subcutaneously. The study is conducted across multiple centers with participants randomly assigned to one of the treatment groups. The treatment period includes monitoring of changes in lipoproteina levels over various weeks to assess the drugs impact. During the study, participants will have regular assessments including measuring lipoproteina levels at baseline and throughout weeks 8 to 52. Researchers will also track the proportion of participants achieving specific target levels of lipoproteina. Safety and efficacy will be closely monitored, with the primary focus on the percent change in lipoproteina from baseline during the treatment period. The total study duration extends until 2028 with primary completion expected by early 2027.

Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)