A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic … (NCT05143177) | Clinical Trial Compass
SuspendedPhase 2/3
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)
Stopped: The study is suspended due to sponsor's business decision. There were no safety issues influencing this course of action.
United States, Canada580 participantsStarted 2022-06-27
Plain-language 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.
Who can participate
Age range
35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Subject provides written informed consent prior to initiation of any study procedures.
. Subject understands and agrees to comply with planned study procedures.
Exclusion criteria
. Subject has concomitant moderate or more aortic valve regurgitation.
. Subject has concomitant moderate or severe mitral or tricuspid valve disease.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is currently suspended — do you know why it's been suspended, and does that affect whether it might be a realistic option for me down the road?
2Since this is a Phase 2/3 trial testing evogliptin for calcific aortic valve disease, what do we know so far about how safe and effective this drug actually is, given it hasn't fully completed this phase of testing?
3The trial measures changes in aortic valve calcification over 104 weeks using cardiac CT — is that two-year commitment and repeated CT scanning realistic given my current health situation and how quickly my aortic stenosis might progress?
4My stenosis is described as mild to moderate — given where I am on that spectrum, would you recommend focusing on monitoring and standard care first, or is exploring an experimental approach like this one worth discussing seriously?
5Are there any other studies or standard treatment options currently available for calcific aortic valve disease that you think I should weigh against waiting to see if this trial reopens?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Aortic valve calcification as measured by change from baseline in Agatston arbitrary unit (AU) using cardiac computed tomography (CT) at 104 weeks