NCT07771465 Danicamtiv Familial Dilated Cardiomyopathy Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07771465 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 1 September 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07771465 is a hot trial to watch
Familial Dilated Cardiomyopathy is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07771465 is notable because it evaluates Danicamtiv in a Phase 3 design sponsored by Kardigan, Inc.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07771465 |
| Official title | A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy (KINSHIP-OLE) |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | Danicamtiv |
| Sponsor | Kardigan, Inc. |
| Geography | Sweden, Netherlands, Hungary, Belgium, United States, Poland, Denmark, United Kingdom, Italy, France, Spain |
| Enrollment | 332 |
| Primary endpoint | Frequency and severity of treatment-emergent adverse events (TEAEs) |
| Endpoint time frame | 61 months |
| Primary completion / readout proxy | Not reported |
Protocol design and endpoint interpretation
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.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 332 participants across Sweden, Netherlands, Hungary, Belgium, United States, Poland, Denmark, United Kingdom, Italy, France, Spain shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- 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)
Readout outlook and evidence gap
The current protocol points to Not reported as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Danicamtiv is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Kardigan, Inc. is resolved to a normalized organization record in United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07771465 provides a focused lens on Familial Dilated Cardiomyopathy development. Its value will be determined by whether Danicamtiv can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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