Evogliptin for Aortic Stenosis

Recruiting at 32 trial locations

Overseen By Nima Sabbaghian, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: REDNVIA Co., Ltd.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 3 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 3 arms in this study to which patients will be randomized in a ratio of 1:1:1 to receive the DA-1229 or placebo orally once daily for a period of 104 weeks . the 3 arms are: placebo, DA-1229 5mg GroupDA-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.

Research Team

Jae K Oh, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

Subject understands and agrees to comply with planned study procedures

I am 35 years old or older.

I have mild to moderate aortic stenosis confirmed by heart scans.

Exclusion 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.

Pregnant or lactating women

Treatment Details

Interventions

• Evogliptin (Dipeptidyl Peptidase-4 (DPP-4) Inhibitor)
• Placebo (Drug)

Trial Overview 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.

Participant Groups

Group I: DA-1229 5mg Active Control 1 Intervention

Group II: DA-1229 10 mg Active Control 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

REDNVIA Co., Ltd.

Lead Sponsor

Trials

2

Recruited

1,100+