Recruiting

Phase 2

Phase 3

AtaciguatAtaciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study

Sponsor:

Kardigan, Inc.

Code:

NCT07001800

Conditions

Moderate Aortic Valve Stenosis

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Ataciguat

Placebo

Study Details

Brief summary:

The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.

Conditions

Moderate Aortic Valve Stenosis

Study ID

NCT07001800

Start date

Jun 27, 2025

Status verified date

May, 2026

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Adult male or female at least 50 years of age
2. Has moderate CAVS as defined by:

1. An AVA of ≥1.0 cm2 to ≤1.50 cm2
2. An AVC score between >300 to 1200 Agatston units (AU) for women and between >300 to 2000 AU for men
3. Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Imaging Core Laboratory
4. For participants in CPET sub-study in Part A and all participants in Part B: If on beta blockade, the dose must be stable for at least 90 days prior to the Screening Visit with no anticipated changes during the study

Key Exclusion Criteria:

1. For participants in the CPET sub-study in Part A and all participants in Part B: Has any medical or physical condition that, in the Investigator's opinion, could lead to an inability to complete Protocol-required CPET procedures (eg, pulmonary disease, joint, leg, hip, back conditions that limit physical activity, or other absolute contraindications for CPET)
2. Anticipated or planned prior aortic valve replacement, repair, surgery, or intervention in the next 6 months
3. Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
4. Has suspected or known congenital aortic valve disease including bicuspid aortic valve
5. New York Heart Association (NYHA) Class IV heart failure symptoms and/or requires continuous inotropes
6. Has history of hypertrophic, genetic/familial cardiomyopathy or cardiomyopathy related to amyloid or sarcoid
7. Has untreated obstructive coronary artery disease or anticipating coronary stenting surgery
8. Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation

Study Design

Enrollment

1276 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ataciguat

placebo comparator: Placebo

Interventions

Ataciguat

Ataciguat will be administrated daily for up to 156 weeks

Placebo

Placebo will be administrated daily for up to 156 weeks

Primary outcome measure

(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 ]

Central Contacts and Locations

Central contacts

Kardigan Clinical Trial Information Team

1-877-310-5135 clinicaltrials@kardigan.bio

Locations

University of Alabama at Birmingham (UAB) - Medical Center

Recruiting

Birmingham, Alabama, United States, 35233

Contacts