Recruiting
Phase 2
Phase 3

Danicamtiv

Sponsor:

Kardigan, Inc.

Code:

NCT07210723

Conditions

Symptomatic Genetic Dilated Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

danicamtiv

Placebo

Study Details

Brief summary:

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:

  • To assess the effect of danicamtiv on cardiac function using echocardiogram.
  • To evaluate the impact of danicamtiv on exercise capacity
  • To evaluate the safety and tolerability of danicamtiv

Participants will:

  • Take danicamtiv or placebo every day for approximately 6 months
  • Visit the clinic about 12 times for initial evaluation, checkups, tests and follow up

Conditions

Symptomatic Genetic Dilated Cardiomyopathy

Study ID

NCT07210723

Start date

Feb 13, 2026

Status verified date

Mar, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Has a diagnosis of DCM due to probable disease-causing variants of MYH7, TTN, or other identified genetic DCM variants, or with familial DCM
2. Has New York Heart Association (NYHA) Class II-IV at Screening with stable symptoms for ≥1 month.
3. Has at least mild left ventricular enlargement (LVE) and has adequate acoustic windows to enable accurate TTEs according to the Echocardiography Core Laboratory.
4. Has a LVEF of ≤45%.
5. Is on stable doses of maximally tolerated standard-of-care heart failure (HF) therapies reflecting current guidelines for at least 4 weeks prior to the first visit.
6. Has DCM not attributed to substance abuse, amyloidosis, sarcoidosis, or any other secondary form of cardiomyopathy per the Investigator.
7. Can perform an upright cardiopulmonary exercise training (CPET) with a peak oxygen uptake (pV̇O2) of 80% or less of predicted for a healthy individual and respiratory exchange ratio (RER) of ≥1.05

Key Exclusion Criteria:

1. Has heart failure with reduced ejection (HFrEF) caused primarily by ischemic heart disease, chronic valvulopathy, or another condition, as determined by the Investigator.
2. Recent (<90 days) clinically significant cardiac events, including acute coronary syndrome, hemodynamically significant epicardial coronary disease (per Investigator), coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]), or hospitalization for heart failure/intravenous (IV) diuretic use.
3. Presence of disqualifying cardiac rhythms that might interfere with reliable echocardiographic measurements of left ventricle (LV) function, as determined by the Investigator including: (a) inadequately rate-controlled atrial fibrillation, (b) ectopic beats (atrial, junctional or ventricular) of sufficient frequency (e.g. > 10% of total beats) that the participant's cardiac rhythm is irregular potentially interfering with reliable echocardiographic measurements of LV function.
4. Unstable or untreated severe ventricular arrythmia (eg, ventricular tachycardia or ventricular fibrillation).
5. History of malignancy of any type within 5 years prior to Screening
6. Severe renal insufficiency (defined at the time of Screening as current estimated glomerular filtration rate \[eGFR\] <15 mL/min/1.73m2 by simplified Modification of Diet in Renal Disease equation \[sMDRD\]).
7. History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Sponsor, would pose a risk to participant safety or interfere with the study evaluation
8. History of heart transplantation or anticipated heart transplantation in the next 6 months.
9. Ongoing or anticipated advanced cardiac interventions, including chronic IV inotropic therapy, planned cardiac resynchronization therapy (CRT) or major surgery, or current/anticipated ventricular assist device placement within 6 months
10. Clinically significant laboratory abnormalities at Screening

Study Design

Enrollment

332 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: danicamtiv

placebo comparator: placebo

Interventions

danicamtiv

Danicamtiv will be administrated twice daily for up to 26 weeks

Placebo

Placebo will be administrated twice daily for up to 26 weeks

Primary outcome measure

  • 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 ]

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

Cedars Sinai

Recruiting

Los Angeles, California, United States, 90048

Contacts

Kardigan Clinical Trial Team

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

University of California, San Diego (UCSD) - Medical Center

Recruiting

San Diego, California, United States, 92037

Contacts

Kardigan Clinical Trial Team

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

UCSF

Recruiting

San Francisco, California, United States, 94158

Contacts

Kardigan Clinical Trial Team

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

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Kardigan Clinical Trial Team

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

Mayo Clinic - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Kardigan Clinical Trial Team

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

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Kardigan Clinical Trial Team

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

Louisiana State University (LSU) Health Sciences Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Kardigan Clinical Trial Team

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

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Kardigan Clinical Trial Team

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

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Kardigan Clinical Trial Team

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

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Kardigan Clinical Trial Team

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

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Kardigan Clinical Trial Team

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

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Kardigan Clinical Trial Team

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

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68106

Contacts

Kardigan Clinical Trial Team

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

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Kardigan Clinical Trial Team

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

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27708

Contacts

Kardigan Clinical Trial Team

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

The Lindner Center for Research and Education at The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Kardigan Clinical Trial Team

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

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Kardigan Clinical Trial Team

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

Oregon Health & Science University (OHSU)

Recruiting

Portland, Oregon, United States, 97239

Contacts

Kardigan Clinical Trial Team

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

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Kardigan Clinical Trial Team

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

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Kardigan Clinical Trial Team

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

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Kardigan Clinical Trial Team

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

More Information

Sponsor

Kardigan, Inc.

Last update posted

Aug 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kardigan, Inc. on 2026-08-04.