Novo Nordisk faces setback as CLARION-CKD trial fails, leading to significant financial impairment

Novo Nordisk, a global leader in pharmaceuticals, has announced a major setback as its CLARION-CKD phase 3 trial failed to meet its primary endpoint, prompting the company to recognize an impairment loss of approximately DKK 5.7 billion. The trial, which was a pivotal part of Novo Nordisk’s efforts in addressing uncontrolled hypertension and advanced chronic kidney disease (CKD), was conducted to evaluate the efficacy of the drug candidate ocedurenone, acquired from KBP Biosciences PTE., Ltd. in 2023.

The phase 3 trial, known as CLARION-CKD, aimed to assess changes in systolic blood pressure from baseline to week 12 among patients. However, an independent data monitoring committee determined during a prespecified interim analysis that the trial met the futility criteria, indicating no significant improvement in the primary endpoint. Consequently, Novo Nordisk has decided to halt the CLARION-CKD trial immediately.

This decision will result in a significant financial impact for Novo Nordisk, with an estimated negative effect of around 6 percentage points on the company’s operating profit growth at constant exchange rates (CER) for 2024. This is a substantial deviation from the operating profit outlook previously communicated in the company’s financial report for the first quarter of 2024.

Despite the disappointing results of the CLARION-CKD trial, Novo Nordisk is evaluating the further development of ocedurenone in other potential indications. Ocedurenone, characterized as a third-generation, non-steroidal, mineralocorticoid receptor antagonist (MRA) with a unique pharmacokinetic profile, including a long half-life and high receptor affinity, still holds promise in different therapeutic areas.

The initial success in phase 2b BLOCK-CKD study, where ocedurenone met its primary endpoint with clinical and statistical significance, had previously set high expectations for the phase 3 trial. The comprehensive study involved more than 600 patients randomized across over 150 sites worldwide, underscoring the scale and significance of the trial.

The failure of the CLARION-CKD trial represents a significant challenge for Novo Nordisk in its quest to expand its portfolio into treatments for chronic kidney disease and hypertension. Such setbacks are not uncommon in the pharmaceutical industry and highlight the risks associated with developing new treatments. It also emphasizes the importance of robust clinical trials to ascertain the efficacy and safety of new drug candidates.

Looking ahead, Novo Nordisk plans to disclose its financial results for the first six months of 2024 and provide an updated financial outlook for the year on August 7, 2024. The company remains committed to pursuing innovative solutions and leveraging its research and development capabilities to overcome this hurdle.