A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy

NCT07771465 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: DAN-302
• Study Type: interventional
• Target: 332
• Locations: 11 countries
• Sites: 78

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)

Outcome Measures

Primary Outcomes (8)

• Frequency and severity of treatment-emergent adverse events (TEAEs)

  61 months

• Frequency and severity of adverse events of special interest (AESIs)

  61 months

• Frequency and severity of serious adverse events (SAEs)

  61 months

• Frequency and severity of disease-related events (DREs)

  61 months

• Frequency of abnormal findings from physical examination

  61 months

• Frequency of abnormal findings from vital signs

  61 months

• Frequency of abnormal findings from 12-lead electrocardiograms (ECGs)

  61 months

• Frequency of abnormal findings from clinical laboratory assessments

  61 months

Secondary Outcomes (6)

• Change from Baseline (Day 1) to Week 26, Months 18, 30, 42, 54, 60, and 61 in cardiac structure, function, and size using Transthoracic Echocardiogram (TTE)

  61 months

• Change from Baseline (Day 1) to Week 26, Months 12, 18, 24, 30, 36, 42, 48, 54, 60, and 61 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-23 CSS)

  61 months

• Change from Baseline (Day 1) to Week 26, Months 12, 18, 24, 30, 36, 42, 48, 54, 60, and 61 in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Utility Score

  61 months

• Change from Baseline (Day 1) to Week 26, Months 12, 18, 24, 30, 36, 42, 48, 54, 60, and 61 in EuroQol Visual Analogue Scale (EQ-VAS) Score

  61 months

• Proportion of participants from Baseline (Day 1) to Week 26, Months 12, 18, 24, 30, 36, 42, 48, 54, 60, and 61 who achieve at least a one-class improvement in New York Heart Association (NYHA) class

  61 months

Study Arms (1)

Danicamtiv

EXPERIMENTAL

Drug: Danicamtiv

Interventions

Danicamtiv DRUG

Danicamtiv will be administered twice daily for up to 5 years

Danicamtiv

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• If sexually active, must use a highly effective birth control method from the Screening Visit through 3 months after the last dose.
• 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.

You may not qualify if:

• 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.
• Recent (\<90 days) hospitalization for heart failure (HF) or use of IV diuretic.
• Other recent (\<90 days) cardiovascular events (e.g., cerebrovascular accident).
• 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.
• Any malignancy requiring treatment after enrollment in DAN-301 that could limit patient's survival.

Sponsors & Collaborators

• Kardigan, Inc.: lead

Study Sites (78)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Cedars Sinai

Los Angeles, California, 90048, United States

RECRUITING

University of California, Los Angeles (UCLA) - David Geffen School of Medicine

Los Angeles, California, 90095, United States

NOT YET RECRUITING

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

San Diego, California, 92037, United States

NOT YET RECRUITING

University of California, San Francisco (UCSF)

San Francisco, California, 94158, United States

NOT YET RECRUITING

Stanford University Medical Center

Stanford, California, 94305, United States

NOT YET RECRUITING

MedStar Washington Hospital Center

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

NOT YET RECRUITING

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Louisiana State University (LSU) Health Sciences Center

New Orleans, Louisiana, 70112, United States

NOT YET RECRUITING

Johns Hopkins Medicine

Baltimore, Maryland, 21218, United States

NOT YET RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

NOT YET RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

NOT YET RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Saint Luke's Mid America Heart Institute

Kansas City, Missouri, 64111, United States

NOT YET RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63110, United States

NOT YET RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68106, United States

NOT YET RECRUITING

NYU Langone Health

New York, New York, 10016, United States

NOT YET RECRUITING

Columbia University Medical Center/ New York Presbyterian Hospital

New York, New York, 10027, United States

NOT YET RECRUITING

Duke University Medical Center

Durham, North Carolina, 27708, United States

NOT YET RECRUITING

The Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

NOT YET RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

NOT YET RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

NOT YET RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

NOT YET RECRUITING

AZORG - Campus Moorselbaan

Aalst, 9300, Belgium

NOT YET RECRUITING

Universite Libre de Bruxelles (ULB) - Hopital Erasme

Brussels, 1070, Belgium

NOT YET RECRUITING

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, 2650, Belgium

NOT YET RECRUITING

Jessa Ziekenhuis

Hasselt, 3500, Belgium

NOT YET RECRUITING

UZ Leuven

Leuven, 3000, Belgium

NOT YET RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

NOT YET RECRUITING

Rigshospitalet

Copenhagen, 1050, Denmark

NOT YET RECRUITING

Odense University Hospital - Odense

Odense, 5000, Denmark

NOT YET RECRUITING

CHRU de Tours - Hopital Trousseau

Chambray-lès-Tours, 37170, France

NOT YET RECRUITING

CHU de Lille - Institut Coeur Poumon

Lille, 59037, France

NOT YET RECRUITING

AP-HP Hopital Pitie-Salpetriere

Paris, 75013, France

NOT YET RECRUITING

AP-HP Hopital Europeen Georges Pompidou

Paris, 75015, France

NOT YET RECRUITING

CHU Rennes - Hopital Pontchaillou

Rennes, 35033, France

NOT YET RECRUITING

Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika

Budapest, 1122, Hungary

NOT YET RECRUITING

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, 6724, Hungary

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Consorziale - Policlinico Bari

Bari, 70124, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria Careggi

Florence, 50314, Italy

NOT YET RECRUITING

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

NOT YET RECRUITING

Centro Cardiologico Monzino

Milan, 20138, Italy

NOT YET RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

NOT YET RECRUITING

Azienda Ospedale - Università Padova

Padova, 35128, Italy

NOT YET RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

NOT YET RECRUITING

Ospedale Policlinico Casilino

Roma, 00169, Italy

NOT YET RECRUITING

Istituto Clinico Humanitas

Rozzano, 20089, Italy

NOT YET RECRUITING

Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara

Trieste, 34100, Italy

NOT YET RECRUITING

Amsterdam UMC - Locatie AMC

Amsterdam, 1105-AZ, Netherlands

NOT YET RECRUITING

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

NOT YET RECRUITING

Erasmus MC

Rotterdam, 3015 GD, Netherlands

NOT YET RECRUITING

Uniwersyteckie Centrum Kliniczne, Gdansk

Gdansk, 80-952, Poland

NOT YET RECRUITING

Krakowski Szpital Specjalistyczny im. sw. Jana Pawla II

Krakow, 31-202, Poland

NOT YET RECRUITING

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, 92-213, Poland

NOT YET RECRUITING

Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy w Warszawie

Warsaw, 04-628, Poland

NOT YET RECRUITING

Hospital Universitario de A Coruña

A Coruña, 15006, Spain

NOT YET RECRUITING

Hospital Universitario Vall d'Hebron, Horta-Guinardó

Barcelona, 08035, Spain

NOT YET RECRUITING

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

NOT YET RECRUITING

Hospital Universitario Puerta de Hierro, Majadahonda, Madrid 20222

Madrid, 20222, Spain

NOT YET RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, 29001, Spain

NOT YET RECRUITING

Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

NOT YET RECRUITING

Hospital Universitario Son Llatzer, Palma De Mallorca,

Palma de Mallorca, 7198, Spain

NOT YET RECRUITING

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

NOT YET RECRUITING

Sodersjukhuset AB

Stockholm, 11883, Sweden

NOT YET RECRUITING

Danderyds sjukhus

Stockholm, 182 88, Sweden

NOT YET RECRUITING

University Hospitals Bristol NHS Foundation Trust

Bristol, BS1 3NU, United Kingdom

NOT YET RECRUITING

NHS Greater Glasgow and Clyde

Glasgow, G12 0YN, United Kingdom

NOT YET RECRUITING

Glenfield hospital

Leicester, LE3 9QP, United Kingdom

NOT YET RECRUITING

St. Bartholomew's Hospital

London, EC1A, United Kingdom

NOT YET RECRUITING

St George's Hospital

London, SW17 0QT, United Kingdom

NOT YET RECRUITING

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

NOT YET RECRUITING

Hammersmith Hospital, Imperial College of London

London, W12 0HS, United Kingdom

RECRUITING

Cardiovascular Clinical Research Facility (CCRF)

Oxford, OX3 9DU, United Kingdom

NOT YET RECRUITING

Central Study Contacts

Kardigan Clinical Trial Information Team

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Global, multicenter study of danicamtiv in participants with symptomatic genetic or familial DCM who previously completed Part 1 or Part 2 of DAN-301 study. Once eligibility is confirmed, participants will receive danicamtiv twice daily dosing.

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 18, 2026
• Study Start: August 26, 2026
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): January 1, 2033
• Last Updated: October 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5); HU (2); IT (10); ES (8); PL (4); SE (2); GB (8); BE (5); DK (3); NL (3); US (28)