An Adaptive Phase 2/3 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel, 3 Arm Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient’s Calcific Aortic Valve Disease with Mild to Moderate Aortic Stenosis (EVOID-AS)

The primary objective of this study is to evaluate the efficacy of DA-1229 versus placebo in reducing the progression of aortic valve calcification as measured by cardiac computed tomography (CT) aortic valve calcium score.

Inova Fairfax Hospital
3300 Gallows Rd.
Falls Church, VA 22042

• Male or female adult ≥ 35 years of age at time of screening
• Subject has calcific aortic valve disease with mild to moderate aortic stenosis as defined by
  • Doppler echocardiography results: Aortic Valve mean pressure gradient between 10-30 mmHg and Aortic Valve Area ≥ 1.2 and ≤ 2.0 cm2 on TTE within 2 weeks prior to randomization and,
  • Cardiac Compute Tomography (CT) test results: aortic valve calcium score (Agatston score) ≥ 200 AU at baseline cardiac CT within 1 month prior to randomization
• Subject provides written informed consent prior to initiation of any study procedures
• Subject understands and agrees to comply with planned study procedures

• Subject has concomitant moderate or more aortic valve regurgitation
• Subject has concomitant moderate or severe mitral or tricuspid valve disease
• Subjects has left ventricular ejection fraction < 50%
• Subject previous history of aortic valve surgery
• Subject has NYHA class III or IV heart failure
• Subjects whose alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 times the upper limit of normal range
• Subjects who cannot undergo Cardiac CT
• Subjects whose life expectancy is < 2 years
• Subjects with ESRD (End-stage Renal Disease) defined as eGFR (calculated using MDRD equation) ≤ 30 mL/min/1.73m2 or in need of dialysis
• Subject has diabetes mellitus
• Subject has history of pancreatitis

For additional information, visit https://classic.clinicaltrials.gov/ct2/show/NCT05143177