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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Symptomatic Genetic Dilated Cardiomyopathy

In brief

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

Key facts

Study ID

NCT07210723

Run by

Kardigan, Inc.

People needed

332

Starts

2026-02-13

Expected to finish

2028-01-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• AZORG - Campus Moorselbaan — Aalst, Belgium (enrolling)
• Universite Libre de Bruxelles (ULB) - Hopital Erasme — Brussels, Belgium (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)
• University of Alabama Birmingham — Birmingham, Alabama, United States (enrolling)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• University of California, San Diego (UCSD) - Medical Center — San Diego, California, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Cedars Sinai — Los Angeles, California, United States (enrolling)
• UCSF — San Francisco, California, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Henry Ford Health System — Detroit, Michigan, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic Rochester — Rochester, Minnesota, United States (enrolling)
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States (enrolling)
• Washington University in St. Louis — St Louis, Missouri, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Louisiana State University (LSU) Health Sciences Center — New Orleans, Louisiana, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• The Lindner Center for Research and Education at The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• Oregon Health & Science University (OHSU) — Portland, Oregon, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Universitair Ziekenhuis Antwerpen (UZA) — Edegem, Belgium (enrolling)

Full record on ClinicalTrials.gov

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