Novo Nordisk announced on June 26, 2024, that its CLARION-CKD Phase 3 trial for ocedurenone, an experimental hypertension drug, failed to meet its primary endpoint. The trial, investigating the drug for uncontrolled hypertension in patients with advanced chronic kidney disease, aimed to measure the change in systolic blood pressure from baseline to week 12. An independent data monitoring committee concluded that the trial met prespecified futility criteria, leading Novo Nordisk to stop the study.
This trial failure will result in an impairment loss of approximately 5.7 billion Danish crowns (around $817 million) for Novo Nordisk in the second quarter of 2024. This impairment charge is expected to have a negative impact of about 6 percentage points on the company's operating profit growth at constant exchange rates for 2024, compared to its previously communicated outlook. Novo Nordisk acquired ocedurenone from KBP Biosciences in October 2023.
The setback adds pressure on Novo Nordisk, which recently experienced a significant share slump in February after its next-generation obesity drug, CagriSema, underperformed a rival drug from Eli Lilly. That event wiped out $475 billion in market value since its peak. However, it's important to note that the CLARION-CKD trial failure is distinct from the issues related to CagriSema or Wegovy's heart failure indication.
Separately, Novo Nordisk had also withdrawn a filing for Wegovy's heart failure indication from the FDA in January, planning to resubmit in 2025 with additional data, including from the FLOW trial, which investigated semaglutide in chronic kidney disease patients with type 2 diabetes. This decision was made to further substantiate the likelihood of getting hard endpoints into the label update for Wegovy, which already has an expanded US label for cardiovascular risk reduction based on the SELECT trial data. Novo Nordisk is also evaluating the further development of ocedurenone in other indications.
