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)

Conditions

• Calcific Aortic Valve Disease

Eligibility Criteria

Sex

ALL

Age

35 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Evogliptin — DRUG
  DA-1229 10 mg, 1 tab
• Placebo — DRUG
  DA-1229 Placebo, 1 tab

Study Details

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.

Key Dates

First listed

Dec 3, 2021

Start date

Jun 27, 2022

Status verified

Jun 2025

Primary completion

May 15, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

580 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
• Active Comparator: DA-1229 10 mg

Primary Outcome Measure

Aortic valve calcification as measured by change from baseline in Agatston arbitrary unit (AU) using cardiac computed tomography (CT) at 104 weeks [ Time Frame: at 104 weeks ]

Locations (24)

Find similar trials in Phoenix, AZ