Novo Nordisk ends trial for drug to treat hypertension in patients with advanced CKD
Key takeaways:
- Novo Nordisk has ended a phase 3 clinical trial of ocedurenone, which was aimed to treat hypertension in patients with advanced chronic kidney disease.
- The company will take an approximate $817 million loss.
Novo Nordisk has stopped phase 3 clinical trials for its drug ocedurenone after it failed to meet its primary endpoint for treating uncontrolled hypertension in patients with advanced chronic kidney disease, according to a company press release.
The company will take a Danish krone 5.7 billion loss, about $817 million in U.S. dollars, in the second quarter of 2024.
Novo Nordisk acquired ocedurenone from KBP Biosciences PTE Ltd. in 2023, according to the release. The phase 3 lead indication trial Clarion-CKD was conducted by KBP Biosciences.
“The trial design included a prespecified interim analysis after all trial participants had completed 12 weeks of treatment,” according to the release. “Based on the interim analysis, an independent data monitoring committee concluded that the trial met the prespecified futility criteria – meaning that the trial did not meet its primary endpoint of change in systolic blood pressure from baseline to week 12. As a result, Novo Nordisk has decided to stop the CLARION-CKD trial.”
Novo Nordisk will publish financial results for the first 6 months of 2024 and financial outlook for the remainder of 2024 on Aug. 7, according to the release.
The company ended a trial last October for semaglutide after early results showed the drug was effective in slowing the progression of CKD.
Ocedurenone is a non-steroidal, mineralocorticoid receptor antagonist with a pharmacokinetic profile characterized by a long half-life and high mineralocorticoid receptor affinity, according to the release. More than 600 patients were randomized at more than 150 sites for the Clarion-CKD trial.
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