Novo Nordisk announced that its Phase 3 CLARION-CKD trial for the cardiovascular drug ocedurenone did not meet its primary endpoint, leading to the discontinuation of the trial. The drug, which was being investigated for uncontrolled hypertension in patients with advanced chronic kidney disease (CKD), failed to show a significant change in systolic blood pressure from baseline after 12 weeks of treatment, based on an interim analysis by an independent data monitoring committee.
As a result of the trial's failure, Novo Nordisk will recognize an impairment loss of approximately DKK 5.7 billion (around $817 million) in the second quarter of 2024. This impairment is expected to negatively impact the company's operating profit growth by about 6 percentage points at constant exchange rates for 2024, compared to its previously communicated outlook.
The CLARION-CKD trial was a multicenter, double-blind, placebo-controlled, randomized study involving over 600 patients across more than 150 sites. This setback follows the acquisition of ocedurenone from KBP Biosciences PTE., Ltd. and contrasts with a successful Phase 2b BLOCK-CKD study that achieved its primary endpoint with statistical significance. The financial results for the first six months of 2024 will officially reflect this impairment.
