A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy | NCT07771465 | Trialant

Not yet recruitingInterventionalPhase 3Updated Aug 18, 2026

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

An Open-label Extension Study to Assess the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07771465
Lead Sponsor: Kardigan, Inc.INDUSTRY
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Phase 3
Enrollment: 332Estimated
Last Update Posted: Aug 18, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Nov 2032Estimated
Completion Date: Jan 2033Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: An Open-label Extension Study to Assess the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy
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.
Detailed Description: The Sponsor is studying an investigational medication called danicamtiv to understand its long-term benefits and risks in patients with symptomatic genetic or familial DCM. This study will examine the durability of treatment effects with continued exposure and evaluate appropriateness of chronic dosing over time.

Participants will:

Take the investigational medicine, danicamtiv, twice daily throughout the study, which is up to 5 years

Visit the clinic about 16 times for clinical evaluations and diagnostic tests

Conditions

The medical conditions and diseases this study investigates.

Symptomatic Genetic Dilated Cardiomyopathy (DCM)

Interventions

The treatments and procedures being evaluated in this study.

Danicamtiv

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

Kardigan Clinical Trial Information TeamContact

clinicaltrials@kardigan.bio1-877-310-5135

Locations

Where the study is run and whether each site is currently recruiting.

University of Alabama Birmingham

Birmingham, Alabama 35233, United States

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Kardigan, Inc.INDUSTRY

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