Calcific Aortic Valve DiseasePhase 2/3NCT05143177

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)

A Phase 2/3 study testing Evogliptin in people with Calcific Aortic Valve Disease, run by REDNVIA Co., Ltd. at 25 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 35 years and older
Conditions the study is for: Calcific Aortic Valve Disease
What is being tested?: Evogliptin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 486 participants
Where: 25 sitesin 2 countries
Study dates: 27 Jun 2022to 26 Mar 2026
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 (AVCS) ≥ 200 AU at baseline cardiac CT within 4 weeks 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.

Who cannot join

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 \&lt; 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) \&gt; 2.5 times the upper limit of normal range.

Show all 50Show fewer

Subjects who cannot undergo Cardiac CT.
Subjects whose life expectancy is \&lt; 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 Type 1 diabetes mellitus.
Subject has a history of diabetic ketoacidosis (DKA).
Subject has a history of severe hypoglycemia (blood glucose levels \&lt; 54 mg/dl) within the previous six months prior to screening.
Note: Subjects receiving treatment for their non-type 1 diabetes and without history of DKA or severe hypoglycemia episode in the preceding 6 months who are interested in participating in the trial are recommended to inform/consult their diabetes provider prior to enrollment in the study or IP initiation to discuss if adjustment in their diabetes therapy or other monitoring may be needed.
Subject has pancreatic Amylase isoenzyme and/or Lipase elevation ≥ 3x the upper limit of normal (ULN) at screening or baseline visit, or subject has a history of pancreatitis
Subjects who are currently taking or anticipated to take any of the following medications for the duration of the study:
oDPP4 inhibitor other than the investigational product
▪Subjects taking insulin or sulfonylureas should consult their primary diabetes provider prior to enrollment in the study or IP initiation to discuss if adjustment in their diabetes therapy and/or other monitoring may be needed.
oVitamin K
▪Subjects taking over-the-counter multivitamins containing ≤ 90 mcg/day vitamin K will be allowed to continue use during the study.
oChronic use of any medications that strongly impact hepatic metabolism by way of inducing or inhibiting the CYP3A4 system, giving rise to drug-drug interaction (with the exception of focal or limited topical treatment)
Strong CYP3A4 inducers* including but not limited to barbiturates (phenobarbital), rifampicin/rifabutin, carbamazepine, phenytoin, primidone, St. John's Wort, Efavirenz, griseofulvin, and chronic (\&gt;1 month) supraphysiologic glucocorticoid use (\&gt;7.5 mg/day prednisone or equivalent glucocorticoid dosing).
Strong CYP3A4 inhibitors*including but not limited to protease inhibitors for treatment of HIV/HCV (such as ritonavir, lopinavir, atazanavir, etc.), chronic systemic use of azole antifungals (ketoconazole, fluconazole, itraconazole, voriconazole) and clarithromycin Note: Short-term/temporary use of clarithromycin, azole antifungals or Paxlovid (for treatment of COVID-19) is allowed, but temporary study drug hold during the course of these treatment would be necessary.
Subjects with history of severe allergic reaction to DPP4 inhibitors including anaphylaxis and angioedema.
Subjects with galactose intolerance, lapp lactase deficiency, and glucose-galactose malabsorption.
Subjects with history of severe cerebrovascular diseases (such as cerebral infarction or transient ischemic attack), severe cardiovascular diseases (such as unstable angina, myocardial infarction and life-threatening arrhythmia) within 6 months of screening.
Subjects with history of malignant tumor within the past 3 years prior to Screening Visit (Visit 1) unless cure is expected.
Subjects with history of drug or alcohol abuse. History of cannabis/Marijuana use including recreational use in the last 6 months and an unwillingness to abstain during the course of the study.
oNote: Alcohol abuse is a pattern of drinking that results in harm to one's health, interpersonal relationships, or ability to work. Manifestations of alcohol abuse include the following: Failure to fulfill major responsibilities at work, school, or home, drinking in dangerous situations, such as drinking while driving or operating machinery, legal problems related to alcohol, such as being arrested for drinking while driving or for physically hurting someone while drunk and continued drinking despite ongoing relationship problems that are caused or worsened by drinking
Subjects with history of medication non-compliance.
Pregnant or lactating women.
Subjects who used investigational drugs or devices within 4 weeks or investigational biologics within the last 6 months prior to screening and for the duration of the study.
Inability to provide informed consent or to comply with test requirements.
Subjects with physical (severe hepatic, cardiac, renal, pulmonary, hematological, endocrine, gastrointestinal, etc. conditions) or mental (cognitive, psychiatric, etc. conditions) conditions that may impact their ability to take part in the study.
Consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment.
Women of child-bearing age who are sexually active but decline to take proper contraceptive measures during the study period, unless the female is post-menopausal for at least 2 years or are surgically sterile.
Note: Women of childbearing potential (WOCBP) and Women not of childbearing potential are eligible to participate. Women of childbearing potential should use an approved method of birth control and agrees to continue to use this method for the duration of the study (and for 30 days after taking the last dose of investigational product).
Acceptable methods of contraception include abstinence, female subject/partner\&#39;s use of hormonal contraceptive (oral, implanted, or injected) in conjunction with a barrier method (WOCBP only), female subject/partner\&#39;s use of an intrauterine device (IUD), or if the female subject/partner is surgically sterile or 2 years post-menopausal. All male subjects/partners of WOCBP must agree to consistently and correctly use a condom for the duration of the study and for 30 days after taking the study drug. In addition, subjects may not donate ova or donate sperm for the duration of the study and for 30 days after taking the last dose investigational product.
Withdrawal Criteria:
A subject who is randomized into the study, but who does not complete the study will be considered prematurely discontinued.
At any point during the study all subjects have the right to withdraw without prejudice to future care. Documentation to whether or not each subject completed the clinical study will be recorded. If for any subject, study treatment was discontinued, the reason(s) will be documented.
The Investigator can discontinue a subject at any time if in their clinical judgment it is considered to be medically necessary. Investigators considering discontinuing study treatment should contact the medical monitor prior to such discontinuation. Subjects who have study treatment discontinued will continue to be followed per protocol (i.e., to complete EOT Visit and Visit 11 assessments), whenever possible. Subjects who have study treatment discontinued due to a serious adverse event will be followed until resolution or stabilization of the event. Reasons for subject withdrawal/discontinuation may constitute one of the following:
Voluntary withdrawal of his/her informed consent
Administration of any prohibited medication unless otherwise approved by the investigator(s)
Serious adverse event or adverse drug reaction that causes withdrawal from the study, such as development of acute pancreatitis investigator(s)
Any evidence of pancreatic inflammation on pancreatic imaging (CT Scan or Magnetic resonance cholangiopancreatography (MRCP) or Ultrasound)
Severe breach against this protocol such as breach of any inclusion or exclusion criteria
When Investigator judges aortic valve surgery or procedure is necessary due to progression of disease as per the Critical Pathways presented in American and European Society of Cardiology
Failure to trace the subject - out of contact, etc. - for follow-up observation
Pregnancy
Discontinuation of study by the Sponsor

Trial locations and contacts

25 sites in 2 countries.

Country

City, postcode or hospital

25 sites in 2 countries

United States24 sites

University of Michigan
Ann Arbor, Michigan, 48109
Northside Hospital
Atlanta, Georgia, 30342
University of Colorado
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
The University of Vermont Medical Center
Burlington, Vermont, 05401
Christ Hospital
Cincinnati, Ohio, 45219
OhioHealth Research Institute
Columbus, Ohio, 43214
Henry Ford Health System
Detroit, Michigan, 48202
Inova Health Care Services
Falls Church, Virginia, 22042
Hackensack Meridian Health
Hackensack, New Jersey, 07601
Texas Heart Institute
Houston, Texas, 77030
Mayo Clinic, FL
Jacksonville, Florida, 32224
University of Southern California
Los Angeles, California, 90033
University of Pittsburgh Medical Center
Mechanicsburg, Pennsylvania, 17050
Aurora Research Institute
Milwaukee, Wisconsin, 53215
Rutgers- Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Ichan School of Medicine
New York, New York, 10025
Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania, 19141
Mayo Clinic, AZ
Phoenix, Arizona, 85054
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, 48073
Baycare Health systems
Safety Harbor, Florida, 34695
Stony brook
Stony Brook, New York, 11974

Other trials in United States

Canada1 site

Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
Québec

Other trials in Canada

About this study

Official title: 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)

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
Being tested: Evogliptin, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EvogliptinDrug
Also called DA-1229
DA-1229 10 mg, 1 tab
PlaceboDrug
DA-1229 Placebo, 1 tab

Study groups in NCT05143177
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
DA-1229 10 mg	Active comparator	Not described Receives: Drug: Evogliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Change in aortic stenosis severity as measured by mean pressure gradient using echocardiography at week104 as compared to baseline
Measured: at week104
Change in aortic stenosis severity as measured by aortic valve area (AVA) using echocardiography at week 104 as compared to baseline
Measured: at week104
Time-to-AV intervention to treat aortic stenosis including AV replacement
Measured: at week104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jun 202226 Mar 2026

First posted3 Dec 2021
Study start27 Jun 2022
Primary completion21 Mar 2026
Study completion26 Mar 2026

Why it stopped: The study is terminated due to sponsor's business decision. There were no safety issues influencing this course of action.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Calcific Aortic Valve DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 486 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05143177
Sponsor's protocol ID: TR-CAVD-001
Status last verified: Jun 2025
First submitted: 20 Oct 2021
Last updated: 18 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Padang R, Hodara R, Jan MF, Jain R, Postalian A, Zweig BM, Naqvi TZ, Levine RA, Dal-Bianco JP, Argulian E, Pressman GS, Sengupta PP, Abbas AE, Cheng W, Patel AK, Bhave NM, Chung ES, Sanchecirf CE, Barrett TC, Kort S, Sohn J, Pollak P, Ali MT, Chadderdon S, Zhao Q, Gill E, El Sakr F, Pereira NL, Vella A, Schulte PJ, Bailey KR, Song JK, Oh JK. Efficacy and Safety of Evogliptin in Mild to Moderate Calcific Aortic Valve Stenosis: The EVOID-AS Trial Rationale and Study Design. Mayo Clin Proc. 2026 Nov 2:S0025-6196(26)18711-4. doi: 10.1016/j.mayocp.2026.08.017. Online ahead of print.
PubMed 42969906

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Calcific Aortic Valve Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT05143177
Acronym / sponsor ID: TR-CAVD-001
Conditions: Calcific Aortic Valve Disease
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study is terminated due to sponsor's business decision. There were no safety issues influencing this course of action.
Enrolment: 486 participants (actual)
Lead sponsor: REDNVIA Co., Ltd.Industry (pharma, biotech, devices)
Study start: 27 Jun 2022 (actual)
Primary completion: 21 Mar 2026 (actual)
Study completion: 26 Mar 2026 (actual)
First posted: 3 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
DA-1229 10 mg	Active comparator	Drug: Evogliptin

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (50 listed)

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 \&lt; 50%.
Subject previous history of aortic valve surgery.
Subject has NYHA class III or IV heart failure.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EvogliptinAlso: DA-1229DA-1229 10 mg, 1 tab	Drug	DA-1229 10 mg
PlaceboDA-1229 Placebo, 1 tab	Drug	Placebo

Primary outcome

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

3 secondary outcomes

Change in aortic stenosis severity as measured by mean pressure gradient using echocardiography at week104 as compared to baseline
Time frame: at week104
Change in aortic stenosis severity as measured by aortic valve area (AVA) using echocardiography at week 104 as compared to baseline
Time frame: at week104
Time-to-AV intervention to treat aortic stenosis including AV replacement
Time frame: at week104

Results and safety

The study was stopped early (reason given: The study is terminated due to sponsor's business decision. There were no safety issues influencing this course of action.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
Derived from this study: PubMed 42969906Padang R, Hodara R, Jan MF, Jain R, Postalian A, Zweig BM, Naqvi TZ, Levine RA, Dal-Bianco JP, Argulian E, Pressman GS, Sengupta PP, Abbas AE, Cheng W, Patel AK, Bhave NM, Chung ES, Sanchecirf CE, Barrett TC, Kort S, Sohn J, Pollak P, Ali MT, Chadderdon S, Zhao Q, Gill E, El Sakr F, Pereira NL, Vella A, Schulte PJ, Bailey KR, Song JK, Oh JK. Efficacy and Safety of Evogliptin in Mild to Moderate Calcific Aortic Valve Stenosis: The EVOID-AS Trial Rationale and Study Design. Mayo Clin Proc. 2026 Nov 2:S0025-6196(26)18711-4. doi: 10.1016/j.mayocp.2026.08.017. Online ahead of print.

Related trials for Calcific Aortic Valve Disease

Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Active, not recruiting
Target Value Study to Evaluate the Safety and Efficacy of the Taurus NXT® Transcatheter Aortic Valve System for the Treatment of Severe Calcific Aortic Stenosis
Aortic Stenosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression
Calcific Aortic Valve Disease, AORTIC VALVE DISEASES
Active, not recruiting
DurAVR™ THV EU-EFS
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jae K Oh, MD principal investigator

Mayo Clinic

25 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Evogliptin in people with Calcific Aortic Valve Disease, run by REDNVIA Co., Ltd. at 25 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05143177, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.