Phase 2b Randomized Double‑Blind Dose‑Finding Study of YMI024 on Inflammatory Markers in Adults with Stable Coronary Artery Disease and Elevated hsCRP

Primary objective: To evaluate the dose‑response relationship of YMI024 versus placebo in reducing inflammatory markers in adults with stable coronary artery disease and elevated hsCRP ≥2 mg/L, providing data to define the optimal therapeutic dose.

Secondary objectives:

• Characterize the dose–response profile of YMI024 for lowering inflammatory marker concentrations.
• Assess the change from baseline in inflammatory marker levels for each YMI024 dose compared with placebo.
• Determine the proportion of participants achieving a predefined reduction in inflammatory markers with YMI024 versus placebo.
• Evaluate the safety and tolerability of YMI024 relative to placebo.

The trial enrolled 128 participants, comprising both male and female adults aged 18 to 80 years at screening. All subjects had a confirmed diagnosis of Coronary Artery disease and demonstrated stable disease with high‑sensitivity C‑reactive protein (hsCRP) levels ≥ 2 mg/L, indicating elevated systemic inflammation. Participants were allowed to continue standard therapies for hypertension, hyperlipidemia, diabetes, chronic kidney disease, and heart failure, reflecting a real‑world population with common comorbidities. Selection required signed informed consent and the ability to comply with study procedures, and included individuals with ongoing kidney disease or heart failure provided these conditions were managed according to usual clinical practice.

The study is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding trial evaluating the effect of YMI024 on inflammatory markers in adults with stable coronary artery disease and baseline hsCRP ≥ 2 mg/L; participants meeting inclusion criteria undergo a screening visit for consent, confirmation of diagnosis, and baseline laboratory assessments, after which they are allocated to one of several dose cohorts or placebo and commence the treatment period, with scheduled follow‑up visits for safety monitoring, vital signs, ECGs, and laboratory evaluations throughout the study, culminating in an end‑of‑study visit that captures final efficacy and safety data; the overall trial is planned to recruit from 23 October 2026 to 1 June 2027, with each participant remaining in the study from screening through the final assessment, thereby providing a defined period of involvement for the evaluation of the primary endpoint (change from baseline in log‑transformed IL‑6) and secondary endpoints including changes in log‑transformed IL‑6 and hsCRP, responder status, and safety outcomes.

The investigational medication in this study is YMI024, designated as the test product. YMI024 is supplied in a pharmaceutical form appropriate for the intended route of administration and is allocated to participants according to the dose‑finding schema defined in the protocol. All active treatment arms receive YMI024 at their assigned dose level, with administration occurring at the frequency specified for each cohort.

A matching placebo, identical in appearance to YMI024, is provided to participants assigned to the control arm. The placebo is administered using the same route, dosage form, and schedule as the active product to maintain blinding. Both YMI024 and placebo are given in a double‑blind, parallel‑group design to adults with stable coronary artery disease and elevated high‑sensitivity C‑reactive protein.

Efficacy will be evaluated by measuring the change from baseline in log‑transformed IL‑6. The primary analysis will compare this change between the YMI024 dose groups and placebo.

Secondary efficacy assessments include change from baseline in log‑transformed hsCRP, and responder status defined as hsCRP < 2 mg/L or hsCRP < 1 mg/L (yes/no). All efficacy parameters will be derived from laboratory measurements obtained at baseline and at the end of treatment.