Head-to-head obesity trial disappointment for Novo Nordisk
Novo Nordisk has seen a significant fall in its stock value following disappointing trial results for its obesity treatment CagriSema, which is a fixed dose combination of cagrilintide 2.4mg and semaglutide 2.4mg.
Although CagriSema demonstrated 23% weight loss in the open-label head-to-head Phase III REDEFINE 4 trial, it did not meet the primary endpoint of showing non-inferiority compared to tirzepatide 15mg at 84 weeks.
“CagriSema has the potential to be the first GLP-1/amylin-combination product to reach the market for people living with obesity, documenting that cagrilintide adds to the existing benefits of semaglutide and offers clinically meaningful additive weight loss effects superior to what has been observed with GLP-1 biology alone. Based on the learnings from completed studies we look forward to the REDEFINE 11 readout, and the initiation of the higher-dose CagriSema trial, which are both designed to assess the full weight-loss potential of CagriSema,” said Martin Holst Lange, Executive Vice President, R&D and Chief Scientific Officer.
CagriSema for weight management was submitted to the US FDA in December 2025 based on the REDEFINE 1 and REDEFINE 2 trials, and an FDA decision is anticipated by late 2026.
In the same week, Novo Nordisk announced a significant reduction in the US list price for its semaglutide brands Wegovy (50%) and Ozempic (35%) in an effort to expand access.
“Lowering the list price of Wegovy and Ozempic is the best approach to address the unprecedented opportunity to help more than 100 million people living with obesity and over 35 million people with type 2 diabetes in the United States,” said Jamey Millar, Executive Vice President, US Operations. “The lower list price is intended to connect more people with our innovative medicines, specifically those whose out-of-pocket costs are linked to list price, such as individuals with high-deductible health plans or co-insurance benefit designs.”
