Novo Nordisk has disclosed that the CLARION-CKD phase 3 trial did not meet its primary endpoint. Consequently, the company will record an impairment loss of approximately DKK 5.7 billion related to the intangible asset ocedurenone in the second quarter of 2024.
Novo Nordisk acquired ocedurenone from KBP Biosciences PTE., Ltd. in 2023. The phase 3 CLARION-CKD trial, which evaluated ocedurenone for patients with uncontrolled hypertension and advanced chronic kidney disease, was conducted by KBP Biosciences.
The trial design included a prespecified interim analysis upon the completion of 12 weeks of treatment by all participants. Based on this interim analysis, an independent data monitoring committee determined that the trial met the prespecified futility criteria, indicating that it failed to achieve its primary endpoint of reducing systolic blood pressure from baseline to week 12. Consequently, Novo Nordisk has decided to terminate the CLARION-CKD trial.