A Phase 2/3 interventional study of Ataciguat and Placebo in Moderate Aortic Valve Stenosis, sponsored by Kardigan, Inc.. Recruiting at 74 sites in 2 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Kardigan, Inc. · Phase 2/3, Interventional, and Treatment
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
This study will be conducted in two parts: Part A and Part B. The purpose of Part A is to investigate whether ataciguat slows the progression of aortic valve calcium (AVC) deposition in adults with moderate calcific aortic valve stenosis (CAVS). The safety, tolerability, and pharmacokinetics of ataciguat will also be evaluated. Approximately 132 participants will be enrolled in Part A. Enrollment in Part B will begin once enrollment in Part A is complete. The purpose of Part B is to investigate whether ataciguat slows the rate of aortic valve area (AVA) loss and to evaluate the effect of ataciguat on peak oxygen consumption (VO2) in participants with moderate CAVS. The safety and tolerability of ataciguat will also be evaluated. Approximately 1144 participants will be enrolled in Part B.
Key Inclusion Criteria:
Has moderate CAVS as defined by:
Key Exclusion Criteria:
Drug: Ataciguat
Drug: Placebo
Ataciguat will be administrated daily for up to 156 weeks
Placebo will be administrated daily for up to 156 weeks
(Part A) Change in Aortic Valve Calcium (AVC) score as assessed by non-contrast CT from baseline to Week 24
Time frame: Week 24
(Part B Dual-Primary) Percent change in Aortic Valve Area (AVA) as measured by echocardiogram from baseline to Week 48
Time frame: Week 48
(Part B Dual-Primary) Change in peak VO2 by CPET from baseline to Week 48
Time frame: Week 48
(Part A) Correlation in the change in AVC as assessed by non-contrast CT and change in VO2 at Week 48
Time frame: Week 48
(Part A) Change in VO2 from baseline to Week 48
Time frame: Week 48
Change in left ventricular diastolic function as assessed by E/e' from baseline to Week 48
Time frame: Week 48
(Part A) Change in Left Ventricular Mass Index (LVMI) from baseline to Week 48
Time frame: Week 48
(Part A) Change in Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) from baseline to Week 48
KCCQ-23 is a patient reported outcome instrument with minimum score = 0 and maximum score = 100 where higher score indicates better health status. There are no units to the score.
Time frame: Week 48
(Part B) Change in AVC score as assessed by non-contrast CT from baseline to Week 48
Time frame: Week 48
(Part B) Time to decision to proceed with TAVR/SAVR or all-cause death
Time frame: Week 158
(Part B) Percentage of participants with progression to AVA <1.0cm2 at Week 48
Time frame: Week 48
Plan to share: No
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Kardigan, Inc.