AURORA (HFpEF)

• Research type

  Research Study

• Full title

  A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)

• IRAS ID

  1011859

• Contact name

  Joana Radcliffe Stevens

• Contact email

  CRGUKStart-upteam.SM@thermofisher.com

• Sponsor organisation

  Bristol-Myers Squibb Services Unlimited Company

• Clinicaltrials.gov Identifier

  NCT06122779

• Research summary

  MYK-224 is an investigational drug being developed for the treatment of heart failure with preserved ejection fraction (HFpEF). The purpose of this study is to understand the safety of MYK-224 in participants with HFpEF and to evaluate any side effects that patients may experience during the study period.

  The study will include about 160 study participants globally. All sites in UK will be NHS sites. Patients will receive either:

  • MYK-224 for the entire study treatment period (20 weeks) OR
  • Placebo for the entire study treatment period (20 weeks)

  Patients will be in the study for up to 28 weeks divided into three stages:

  • Up to 4-week screening period
  • 20-week treatment period, and
  • 4-week follow-up

  For more information on eligibility, procedures and risks, please read the full ICF summary and Main Informed Consent Form.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  25/NW/0130

• Date of REC Opinion

  22 Jul 2025

• REC opinion

  Further Information Favourable Opinion