NCT05143177

A 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)

An Adaptive Phase 2/3 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel, 2 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)

• Status: Suspended
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 580 (estimated)
• Sponsor: REDNVIA Co., Ltd. · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

This is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 2 arm study to evaluate the efficacy and safety of DA-1229 compared to placebo in patients with calcific aortic valve disease with mild to moderate aortic stenosis. There are 2 arms in this study to which patients will be randomized in a ratio of 1:1 to receive the DA-1229 or placebo orally once daily for a period of 104 weeks. The 2 arms are: placebo and DA-1229 10 mg Group. The study will have three phases: Screening Period (up to 4 weeks), Treatment Period (104 weeks), and Follow-Up Period (2-4 weeks). Total Study Duration is112 Weeks.

Conditions

• Calcific Aortic Valve Disease

Interventions

Type	Name	Description
DRUG	Evogliptin	DA-1229 10 mg, 1 tab
DRUG	Placebo	DA-1229 Placebo, 1 tab

Timeline

• Start date: 2022-06-27
• Primary completion: 2026-05-15
• Completion: 2026-12-30
• First posted: 2021-12-03
• Last updated: 2026-03-27

Locations

25 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study