A Phase 2/3 interventional study of danicamtiv and Placebo in Symptomatic Genetic Dilated Cardiomyopathy, sponsored by Kardigan, Inc.. Recruiting at 78 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Kardigan, Inc. · Phase 2/3, Interventional, and Treatment
The Sponsor is studying an investigational medication called danicamtiv to determine if it can help people with genetic and familial dilated cardiomyopathy (DCM). Investigational means that the safety and effectiveness of danicamtiv have not been established. Currently, there are no approved drugs that are designed specifically to treat genetic or familial DCM.
The purpose of this study is to evaluate how well danicamtiv works compared to a placebo (sugar pill that looks like danicamtiv pill but does not contain any danicamtiv) and see how safe it is for people with genetic and familial DCM. In DCM, the heart muscle weakens and enlarges, making it harder for the heart to pump blood; this can happen for different reasons. Some people have DCM because of a change in a gene (called genetic DCM). Others may have DCM that runs in their family, even if no specific gene change is found (called familial DCM).
The main goals of the study are:
Participants will:
Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: danicamtiv
Drug: Placebo
Danicamtiv will be administrated twice daily for up to 26 weeks
Placebo will be administrated twice daily for up to 26 weeks
Part 1: Change from Baseline (Day 1) to Week 26 in left atrial function index in Cohort 1
Time frame: 26 weeks
Part 2: Change from Baseline (Day 1) to Week 26 in peak VO2 in Cohort 1
Time frame: 26 weeks
Part 1: Change from Baseline (Day 1) to Week 26 in peak VO2
Time frame: 26 weeks
Part 1: Association between response in left ventricular global longitudinal strain and/or left atrial function index after 2 weeks of active treatment with placebo-adjusted Week 26 response in peak VO2
Time frame: 26 weeks
Part 1: Change from Baseline (Day 1) to Week 26 in left atrial function index in overall population
Time frame: 26 weeks
Part 1 and 2: Change from Baseline (Day 1) to Week 26 in left ventricular ejection fraction
Time frame: 26 weeks
Part 1 and 2: Change from Baseline (Day 1) to Week 26 in ventilatory efficiency
Time frame: 26 weeks
Part 1 and 2: Change from Baseline (Day 1) to Week 26 in Kansas City Cardiomyopathy Questionnare (KCCQ-23) Clinical Summary Score
All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Time frame: 26 weeks
Part 1: Proportion of participants from Baseline (Day 1) to Week 26 who achieve at least a one-class improvement in New York Heart Association (NYHA) class
NYHA is a system used to categorize the severity of heart failure symptoms based on a patient's functional capacity, where 1 indicates no symptoms or limitations and 4 indicates symptoms present at rest.
Time frame: 26 weeks
Part 2: Change from Baseline (Day 1) to Week 26 in left atrial function index
Time frame: 26 weeks
Part 2: Change from Baseline (Day 1) to Week 26 in peak VO2 in the responder subgroup
Time frame: 26 weeks
Part 2: Change from Baseline (Day 1) to Week 26 in peak VO2 in overall population
Time frame: 26 weeks
Part 1 and 2: Change from Baseline (Day 1) to Week 26 in left ventricular global longitudinal strain
Time frame: 26 weeks
Part 1 and 2: Percent change from Baseline (Day 1) to Week 26 in NT-proBNP concentrations
Time frame: 26 weeks
Part 1 and 2: Characterization of peak (Cmax) of danicamtiv
Time frame: 20 weeks
Part 1 and 2: Characterization of trough (Cmin) plasma concentrations of danicamtiv
Time frame: 20 weeks
Part 1 and 2: Incidence and severity of treatment emergent adverse events, adverse events of special interest, serious adverse events and disease related events
Time frame: 26 weeks
Incidence of abnormal findings in laboratory assessments, physical examinations, 12-lead ECGs, and vital signs
Time frame: 26 weeks
Plan to share: No
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Kardigan, Inc.