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Dipeptidyl Peptidase-4 (DPP-4) Inhibitor
Evogliptin for Aortic Stenosis
Phase 2 & 3
Recruiting
Led By Jae K Oh, MD
Research Sponsored by REDNVIA Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 and Cardiac Compute Tomography (CT) test results
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week104
Awards & highlights
Study Summary
This trial is testing a new drug, DA-1229, for patients with aortic valve disease. The study will last 104 weeks, and patients will be given the drug either once a day or as a placebo. The study will have 3 phases: Screening, Treatment, and Follow-Up.
Who is the study for?
Adults over 35 with mild to moderate calcific aortic valve disease and stenosis, who can undergo heart CT scans and agree to study procedures. Excludes those with diabetes, pancreatitis, severe heart or kidney conditions, life expectancy under 2 years, recent severe cardiovascular events, drug non-compliance history, pregnancy or breastfeeding women not using contraception.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Evogliptin (DA-1229) in patients with aortic valve disease. Participants are randomly assigned to receive either Evogliptin at two different doses (5mg or 10mg) or a placebo daily for 104 weeks.See study design
What are the potential side effects?
Potential side effects may include allergic reactions specific to DPP4 inhibitors like anaphylaxis and angioedema. Other risks could be related to digestive issues due to intolerance mentioned in the exclusion criteria.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 35 years old or older.
Select...
I have mild to moderate aortic stenosis confirmed by heart scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week104
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Aortic valve calcification as measured by change from baseline in Agatston arbitrary unit (AU) using cardiac computed tomography (CT) at 104 weeks
Secondary outcome measures
Change in aortic stenosis severity as measured by aortic valve area (AVA) using echocardiography at week 104 as compared to baseline
Change in aortic stenosis severity as measured by mean pressure gradient using echocardiography at week104 as compared to baseline
Aortic Valve Stenosis
Other outcome measures
Aortic valve calcification as measured by change from baseline in Agatston AU using cardiac computed tomography (CT) at week 52
Change in aortic stenosis severity as measured by aortic valve area (AVA) using echocardiography at week 52 as compared to baseline
Change in aortic stenosis severity as measured by dimensionless velocity using echocardiography at week 104 as compared to baseline
+7 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: DA-1229 5mgActive Control1 Intervention
Group II: DA-1229 10 mgActive Control1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
REDNVIA Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
218 Total Patients Enrolled
Jae K Oh, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate or severe leakage in my aortic heart valve.Your liver enzymes (ALT and AST) are more than 2.5 times the normal range.I haven't used any experimental drugs or devices in the last 4 weeks or biologics in the last 6 months.You have had a serious allergic reaction to DPP4 inhibitors in the past.You have a history of not following your doctor's medication instructions.I have severe kidney disease or need dialysis.I do not have any health conditions that would prevent me from participating in the study.I have had cancer within the last 3 years.I haven't had severe brain or heart issues in the last 6 months.You have a history of using drugs or drinking too much alcohol.I am 35 years old or older.I have mild to moderate aortic stenosis confirmed by heart scans.My heart's pumping ability is below normal.I am a woman able to have children and will not use birth control during the study.I have had surgery on my aortic valve in the past.I have moderate to severe heart valve disease.You are not expected to live for at least 2 more years.I have diabetes.You cannot participate if you have trouble digesting galactose or lactose.I have severe heart failure.I am currently on medication and will continue it during the study.I have had pancreatitis before.You are unable to have a heart CT scan.
Research Study Groups:
This trial has the following groups:- Group 1: DA-1229 5mg
- Group 2: DA-1229 10 mg
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To your knowledge, are there other similar trials underway?
"As of now, 4 trials for DA-1229 10 mg are underway in 11 cities within 2 nations. The first ever trial for DA-1229 10 mg was in 2019. That year, the study - which was sponsored by Dong-A ST Co., Ltd. - had 225 individuals taking part. It completed its Phase 2 drug approval. In the two years since 2019, a total of 18,281 trials have been completed."
Answered by AI
Are there precedents for giving DA-1229 10 mg to patients?
"As of now, 4 different clinical trials are studying the effects of DA-1229 10 mg. 1 of these trials is currently in Phase 3. Most of the research is taking place in Seoul, Gangwondo; however, there are a total of 19 sites running DA-1229 10 mg trials."
Answered by AI
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