Recruiting
Phase 3

Danicamtiv

Sponsor:

Kardigan, Inc.

Code:

NCT07771465

Conditions

Symptomatic Genetic Dilated Cardiomyopathy (DCM)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Danicamtiv

Study Details

Brief summary:

Danicamtiv is an investigational medication, which means it is still being studied and has not been approved. The purpose of this study is to learn how well danicamtiv works, how safe it is, how well people can take it when used in patients with genetic or familial dilated cardiomyopathy (DCM). There are currently no approved medicines made specifically to treat genetic or familial DCM.

Conditions

Symptomatic Genetic Dilated Cardiomyopathy (DCM)

Study ID

NCT07771465

Start date

Aug 26, 2026

Status verified date

Aug, 2026

Completion date

Jan, 2033

Anticipated

Primary completion date

Nov, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Completed 24 weeks of blinded study treatment (corresponding to the Week 26 Visit in DAN-301) and planned assessments in Part 1 or Part 2 of the DAN-301 study.
2. If sexually active, must use a highly effective birth control method from the Screening Visit through 3 months after the last dose.
3. Is able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent according to local and institutional guidelines before the first study-specific procedure.

Exclusion Criteria:

1. Acute coronary syndrome or hemodynamically significant epicardial coronary disease, or coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]) performed within 90 days of DAN-302 Screening Visit.
2. Recent (<90 days) hospitalization for heart failure (HF) or use of IV diuretic.
3. Other recent (<90 days) cardiovascular events (e.g., cerebrovascular accident).
4. Hospitalization for sepsis or other systemic infections within 30 days of Screening. A systemic infection includes suspected or confirmed infection associated with fever, hemodynamic instability, bacteremia, or organ dysfunction typically requires urgent evaluation and/or acute care.
5. Any malignancy requiring treatment after enrollment in DAN-301 that could limit patient's survival.

Study Design

Enrollment

332 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Danicamtiv

Interventions

Danicamtiv

Danicamtiv will be administered twice daily for up to 5 years

Primary outcome measure

  • Frequency and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: 61 months ]
  • Frequency and severity of adverse events of special interest (AESIs) [ Time Frame: 61 months ]
  • Frequency and severity of serious adverse events (SAEs) [ Time Frame: 61 months ]
  • Frequency and severity of disease-related events (DREs) [ Time Frame: 61 months ]
  • Frequency of abnormal findings from physical examination [ Time Frame: 61 months ]
  • Frequency of abnormal findings from vital signs [ Time Frame: 61 months ]
  • Frequency of abnormal findings from 12-lead electrocardiograms (ECGs) [ Time Frame: 61 months ]
  • Frequency of abnormal findings from clinical laboratory assessments [ Time Frame: 61 months ]

Central Contacts and Locations

Central contacts

Kardigan Clinical Trial Information Team

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

Locations

University of Alabama Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Kardigan Clinical Trial Team

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

More Information

Sponsor

Kardigan, Inc.

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kardigan, Inc. on 2026-09-02.