A Study to Investigate Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis (KATALYST-AV)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Kardigan Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-06-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Kardigan, Inc.

External identifiers

EU CT number

2025-522176-86-01

ClinicalTrials.gov

NCT07001800

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Pharmacokinetic, Efficacy

Part B: To determine whether ataciguat slows the rate of AVA loss
Part B: To evaluate the effect of ataciguat on peak VO2

Secondary objectives 2

1. 1. Part B: To determine whether ataciguat slows the rate of AVC deposition
2. 2. Part B: To determine whether ataciguat delays progression to clinically relevant endpoints including: Decision to proceed with TAVR/SAVR; All-cause death; Progression to an AVA <1.0 cm2

Conditions and MedDRA coding

Moderate Calcific Aortic Valve Stenosis (CAVS)

Regulatory references

Scientific advice from competent authorities

Medicines Evaluation Board, Medicines And Healthcare Products Regulatory Agency, Swedish Medical Products Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Adult male or female at least 50 years of age
2. 2. Has moderate CAVS as defined by: a) An AVA of ≥1.0 cm2 to ≤1.50 cm2 b) An AVC score between ≥600 to 1200 Agatston units (AU) for women and between ≥600 to 2000 AU for men on non-contrast CT
3. 3. Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the Imaging Core Laboratory
4. 4. For participants 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
5. 5. Additional criteria as listed in the protocol may apply

Exclusion criteria 9

1. 1. Has a prior aortic valve replacement, repair, surgery, or intervention or an anticipated or planned aortic valve replacement in the next 6 months
2. 2. Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
3. 3. Has suspected or known congenital aortic valve disease including bicuspid aortic valve
4. 4. Has New York Heart Association (NYHA) Class III or Class IV heart failure symptoms
5. 5. Has a primary etiology for heart failure other than aortic valve disease
6. 6. Has coronary artery disease or anticipating coronary stenting surgery
7. 7. Has an average QTcF ≥480 msec at Screening according to the Investigator’s assessment, risk factors for torsades de pointes, such as hypokalemia, a family history of long QT syndrome, or concurrent use of medications that prolong the QT/QTc interval, abnormal electrocardiogram (ECG) results and/or long-standing persistent or permanent atrial fibrillation
8. 8. 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 (e.g. pulmonary disease, joint, leg, hip, back conditions that limit physical activity, or other absolute contraindications for CPET)
9. 9. Additional criteria as listed in the protocol may apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1. (Part B) Percent change in AVA as measured by echocardiogram from baseline to Week 48
2. 2. (Part B) Change in peak VO2 as assessed by CPET from baseline to Week 48

Secondary endpoints 2

1. 1. (Part B) Change in AVC score as assessed by non-contrast CT from baseline to Week 48.
2. 2. (Part B) Time to decision to proceed with TAVR/SAVR or all-cause death; Percentage of participants with AS progression to AVA <1.0cm2 at Week 48

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Kardigan Inc.

Sponsor organisation

Kardigan Inc.

Address

131 Oyster Point Boulevard Second Floor

City

South San Francisco

Postcode

94080-2029

Country

United States

Scientific contact point

Organisation

Kardigan Inc.

Contact name

SM Kardigan Medical Information

Public contact point

Organisation

Kardigan Inc.

Contact name

SM Kardigan Clinical Trials

Third parties 9

Locations

7 EU/EEA countries · 47 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 66 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications