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RECRUITING
NCT07830719
PHASE2

Dose-finding Study of YMI024 to Assess Efficacy, Safety, and Tolerability in Adults With Stable Coronary Artery Disease and Elevated hsCRP

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this Phase 2b study is to investigate the efficacy in reducing systemic inflammation, safety, tolerability, and dose response of five doses of YMI024, as compared to placebo in adult participants with stable coronary artery disease (CAD) and residual inflammatory risk defined by elevated high-sensitivity C-reactive protein (hsCRP) (≥2 mg/L)

Official title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study of YMI024 to Assess Efficacy in Reducing Inflammatory Markers, Safety, and Tolerability in Adults With Stable Coronary Artery Disease and Elevated hsCRP

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-09-18

Completion Date

2027-08-15

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

DRUG

YMI024

YMI024 in different doses

DRUG

Placebo

matching placebo

Locations (23)

Eastern Shore Research Institute

Fairhope, Alabama, United States

G and L Research LLC

Foley, Alabama, United States

Biopharma Informatic LLC

Los Angeles, California, United States

AMR Miami

Coral Gables, Florida, United States

Alliance for Multispecialty Research

Wichita, Kansas, United States

Anderson Medical Research

Ft. Washington, Maryland, United States

MD Medical Research

Oxon Hill, Maryland, United States

Pharma Tex Research

Amarillo, Texas, United States

Selma Medical Associates

Winchester, Virginia, United States

Novartis Investigative Site

Adelaide, South Australia, Australia

Novartis Investigative Site

Frankston, Victoria, Australia

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Mulgrave, Victoria, Australia

Novartis Investigative Site

Stuttgart, Baden-Wurttemberg, Germany

Novartis Investigative Site

Kaiserslautern, Rhineland-Palatinate, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Mannheim, Germany

Novartis Investigative Site

Pirna, Germany

Novartis Investigative Site

Kasugai, Aichi-ken, Japan

Novartis Investigative Site

Matsudo, Chiba, Japan

Novartis Investigative Site

Kamakura, Kanagawa, Japan

Novartis Investigative Site

Matsubara, Osaka, Japan

Novartis Investigative Site

London, United Kingdom