KINSHIP-DCM

• Research type

  Research Study

• Full title

  A Phase 2b/3, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Danicamtiv in Participants with Symptomatic Genetic and Familial Dilated Cardiomyopathy (KINSHIP-DCM)

• IRAS ID

  1012888

• Contact name

  Stuart Heminway

• Contact email

  sheminway@kardigan.bio

• Sponsor organisation

  Kardigan, Inc.

• Research summary

  The Sponsor is studying an investigational medication called danicamtiv to determine if it can help people with genetic and familial dilated cardiomyopathy (DCM). The safety and effectiveness of danicamtiv have not been established. Currently, there are no approved drugs that are designed to treat genetic or familial DCM. In DCM, the heart muscle weakens and enlarges, making it harder for the heart to pump blood. This study will evaluate
  • how well danicamtiv works to treat genetic and familial DCM
  • how danicamtiv works compared to a sugar pill (placebo).
  • how safe it is and how long it stays in the bloodstream
  • how well danicamtiv is tolerated

  This study will include:
  • Men and women at least 18 years of age who are able and willing to consent to take part in the study
  • People with a diagnosis of genetic or familial DCM, as defined in the study protocol
  • People who are infertile or agree to use highly effective contraception
  • Additional inclusion criteria apply

  Participants will go through a screening period of up to 4 weeks to see if they are eligible to participate. If they are, all participants will take either danicamtiv or placebo twice daily orally for 28 weeks. After the last dose, participants will be followed for about 4 weeks. Total study duration will be around 36 weeks unless the study is stopped early for safety reasons, or any other reason described in the study protocol. This is a double-blind study. Neither the participants nor the Sponsor or people at the study site will know who has received which study medication.
  Upon completion, participants may have an option to enrol in an open-label extension study. Participants will have blood tests, physical exams, and tests to check how well their heart is working. These tests include electrocardiograms, ultrasound heart tests, and an exercise test called CPET. Participants will also wear a cardiac patch on their chest and a wrist device, and complete questionnaires.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  25/NW/0311

• Date of REC Opinion

  10 Nov 2025

• REC opinion

  Further Information Favourable Opinion