Novo Nordisk halts clinical trial of diabetes drug due to positive kidney benefits

DENMARK — Novo Nordisk has announced the early termination of a significant clinical trial assessing the efficacy of its diabetes drug, Ozempic, after preliminary data revealed a significant kidney benefit.

This development holds the potential to bolster the case for Ozempic as a treatment for blood sugar control and weight reduction in individuals with Type 2 diabetes, a substantial portion of whom experience chronic kidney disease due to damage to blood vessels and filtering cells in the kidneys.

Ozempic, administered via a once-weekly injection, already holds approval from the Food and Drug Administration (FDA) for the prevention of heart attacks and strokes, which are leading causes of mortality and hospitalization in people with Type 2 diabetes.

The positive results from the study also position Ozempic favorably in the competitive landscape, particularly against Eli Lilly’s latest treatment, Mounjaro.

While Mounjaro has gained approval for diabetes treatment, it is yet to complete the necessary clinical trials to demonstrate its effectiveness in delaying kidney disease or preventing cardiovascular events.

The rivalry between Novo Nordisk and Eli Lilly, two major players in the metabolic disease drug market, is expected to intensify further.

Lilly is currently seeking approval for Mounjaro as a weight loss drug, putting it in direct competition with Novo’s product, Wegovy, which shares the same active ingredient, semaglutide, as Ozempic.

Novo Nordisk, based in Denmark, has not disclosed detailed trial data from the study, referred to as FLOW.

They indicated that the results will remain confidential until the study is fully completed, with a comprehensive report expected in the first half of 2024, according to the company’s statement.

The FLOW trial, initiated in 2019, enrolled 3,500 participants with diabetes and kidney disease, assigning them to receive either Ozempic or a placebo for a planned duration of up to five years.

Researchers closely monitored the participants to identify changes in kidney filtering rates, the onset of end-stage kidney disease, or death resulting from kidney or cardiovascular conditions.

The decision to prematurely conclude the trial stemmed from an independent data monitoring panel’s finding, which indicated that Ozempic significantly reduced the risk of kidney-related conditions, meeting predefined statistical criteria.

As per the trial’s design, Ozempic needed to demonstrate a reduction in the absolute risk of one of these kidney-related conditions by at least 3.5% when compared to the placebo, or a relative risk reduction of approximately 16.5%, as noted by Akash Tewari, an analyst covering Lilly at Jefferies, in a client memo.

Tewari clarified that the trial’s outcomes may not expand the eligible patient population for Ozempic. However, he emphasized that it strengthens the rationale for using the drug in this specific population.

Notably, Boehringer Ingelheim and Lilly’s diabetes pill, Jardiance, recently received FDA approval as a kidney disease treatment in individuals without diabetes. This approval was based on data indicating a relative risk reduction for poor kidney outcomes.

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