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)

Paused · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Calcific Aortic Valve Disease

In brief

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 facts

Study ID

NCT05143177

Run by

REDNVIA Co., Ltd.

People needed

580

Starts

2022-06-27

Expected to finish

2026-12-30

Last updated by the study team

2026-03-27

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 \< 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) \> 2.5 times the upper limit of normal range.
• Subjects who cannot undergo Cardiac CT.
• Subjects whose life expectancy is \< 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 \< 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 (\>1 month) supraphysiologic glucocorticoid use (\>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.

Where it is running

• Mayo Clinic, AZ — Phoenix, Arizona, United States
• University of Southern California — Los Angeles, California, United States
• University of Colorado — Aurora, Colorado, United States
• Mayo Clinic, FL — Jacksonville, Florida, United States
• Baycare Health systems — Safety Harbor, Florida, United States
• Northside Hospital — Atlanta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Beaumont Hospital, Royal Oak — Royal Oak, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Hackensack Meridian Health — Hackensack, New Jersey, United States
• Rutgers- Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Ichan School of Medicine — New York, New York, United States
• Stony brook — Stony Brook, New York, United States
• Christ Hospital — Cincinnati, Ohio, United States
• OhioHealth Research Institute — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Pittsburgh Medical Center — Mechanicsburg, Pennsylvania, United States
• Einstein Medical Center Philadelphia — Philadelphia, Pennsylvania, United States
• Texas Heart Institute — Houston, Texas, United States
• The University of Vermont Medical Center — Burlington, Vermont, United States
• Inova Health Care Services — Falls Church, Virginia, United States
• Aurora Research Institute — Milwaukee, Wisconsin, United States
• Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval — Québec, Canada

Full record on ClinicalTrials.gov

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