RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy

Sponsor: Kardigan, Inc. • ClinicalTrials.gov ID: NCT07210723

Registry updated: 2026-10-05

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Description

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

Interventions

danicamtiv (Drug)
Danicamtiv will be administrated twice daily for up to 26 weeks
Placebo (Drug)
Placebo will be administrated twice daily for up to 26 weeks

Eligibility criteria

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

Conditions

Symptomatic Genetic Dilated Cardiomyopathy

Locations

University of Alabama Birmingham — Birmingham, Alabama, United States
Cedars Sinai — Los Angeles, California, United States
University of California, Los Angeles (UCLA) - David Geffen School of Medicine — Los Angeles, California, United States
University of California, San Diego (UCSD) - Medical Center — San Diego, California, United States
UCSF — San Francisco, California, United States
Stanford University Medical Center — Stanford, California, United States
MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
Northwestern University — Chicago, Illinois, United States
Louisiana State University (LSU) Health Sciences Center — New Orleans, Louisiana, United States
Johns Hopkins Medicine — Baltimore, Maryland, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
Henry Ford Health System — Detroit, Michigan, United States
University of Minnesota — Minneapolis, Minnesota, United States
Mayo Clinic Rochester — Rochester, Minnesota, United States
Saint Luke's Mid America Heart Institute — Kansas City, Missouri, United States
Washington University in St. Louis — St Louis, Missouri, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
NYU Langone Health — New York, New York, United States
Columbia University Medical Center/ New York Presbyterian Hospital — New York, New York, United States
Duke University Medical Center — Durham, North Carolina, United States
The Lindner Center for Research and Education at The Christ Hospital — Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
Oregon Health & Science University (OHSU) — Portland, Oregon, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
Baylor College of Medicine — Houston, Texas, United States
Houston Methodist Hospital — Houston, Texas, United States
AZORG - Campus Moorselbaan — Aalst, Belgium
Universite Libre de Bruxelles (ULB) - Hopital Erasme — Brussels, Belgium
Universitair Ziekenhuis Antwerpen (UZA) — Edegem, Belgium
Jessa Ziekenhuis — Hasselt, Belgium
UZ Leuven — Leuven, Belgium
Aarhus University Hospital — Aarhus, Denmark
Rigshospitalet — Copenhagen, Denmark
Odense University Hospital - Odense — Odense, Denmark
CHRU de Tours - Hopital Trousseau — Chambray-lès-Tours, France
CHU de Lille - Institut Coeur Poumon — Lille, France
AP-HP Hopital Pitie-Salpetriere — Paris, France
AP-HP Hopital Europeen Georges Pompidou — Paris, France
CHU Rennes - Hopital Pontchaillou — Rennes, France
Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika — Budapest, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont — Szeged, Hungary
Azienda Ospedaliera Universitaria Consorziale - Policlinico Bari — Bari, Italy
Azienda Ospedaliero-Universitaria Careggi — Florence, Italy
IRCCS Ospedale San Raffaele — Milan, Italy
Centro Cardiologico Monzino — Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy
Azienda Ospedale - Università Padova — Padova, Italy
Fondazione IRCCS Policlinico San Matteo — Pavia, Italy
Ospedale Policlinico Casilino — Roma, Italy
Istituto Clinico Humanitas — Rozzano, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara — Trieste, Italy
Amsterdam UMC - Locatie AMC — Amsterdam, Netherlands
Maastricht University Medical Center — Maastricht, Netherlands
Erasmus MC — Rotterdam, Netherlands
Uniwersyteckie Centrum Kliniczne, Gdansk — Gdansk, Poland
Krakowski Szpital Specjalistyczny im. sw. Jana Pawla II — Krakow, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi — Lodz, Poland
Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy w Warszawie — Warsaw, Poland
Hospital Universitario Vall d'Hebron — Horta-Guinardó, Barcelona, Spain
Hospital Universitario Puerta de Hierro — Majadahonda, Madrid, Spain
Hospital Universitario de A Coruña — A Coruña, Spain
Hospital Universitari de Bellvitge — Barcelona, Spain
Hospital Universitario Virgen de la Victoria — Málaga, Spain
Hospital Clinico Universitario Virgen de la Arrixaca — Murcia, Spain
Hospital Universitario Son Llatzer — Palma de Mallorca, Spain
Hospital Universitario Virgen del Rocio — Seville, Spain
Sodersjukhuset AB — Stockholm, Sweden
Danderyds sjukhus — Stockholm, Sweden
University Hospitals Bristol NHS Foundation Trust — Bristol, United Kingdom
NHS Greater Glasgow and Clyde — Glasgow, United Kingdom
Glenfield Hospital — Leicester, United Kingdom
St. Bartholomew's Hospital — London, United Kingdom
St George's Hospital — London, United Kingdom
Royal Brompton Hospital — London, United Kingdom
Hammersmith Hospital, Imperial College of London — London, United Kingdom
Cardiovascular Clinical Research Facility (CCRF) — Oxford, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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