In a significant setback for Novo Nordisk, the pharmaceutical giant's stock has plunged to a 52-week low following the disclosure of unsatisfactory results from its REDEFINE 4 clinical trial. This trial, designed to evaluate the effectiveness of its investigational weight-loss treatment, CagriSema, revealed that the drug did not meet expectations when benchmarked against Eli Lilly's rival product, Tirzepatide.
Novo Nordisk's CagriSema Fails to Outperform Eli Lilly's Tirzepatide in Key Weight-Loss Trial
On Monday, February 23, 2026, Novo Nordisk A/S experienced a substantial downturn in its stock valuation. The decline was triggered by the announcement of headline data from the REDEFINE 4 trial, an open-label Phase 3 study forming part of the global REDEFINE clinical program. This disappointing news sent Novo Nordisk shares tumbling by 13.29% to $41.12 in premarket trading, marking a new 52-week low and reflecting an approximate 48% fall over the past year. The REDEFINE 4 trial, spanning 84 weeks and involving 809 participants, aimed to compare CagriSema (a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) with tirzepatide 15 mg, both administered weekly via subcutaneous injection. Eli Lilly and Co.'s tirzepatide is widely recognized under its brand names Zepbound and Mounjaro. The core objective of the trial was to demonstrate that CagriSema was not inferior to tirzepatide in terms of weight loss. However, at the 84-week mark, participants treated with CagriSema achieved an average weight reduction of 20.2%, falling short of the 23.6% observed in the tirzepatide group. Despite this efficacy shortfall, CagriSema maintained a positive safety and tolerability profile, with most adverse events being mild to moderate gastrointestinal issues that subsided over time, consistent with the known effects of GLP-1 receptor agonists. Martin Holst Lange, executive vice president of R&D and chief scientific officer at Novo Nordisk, expressed optimism for future trials. He noted, "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." Data from the REDEFINE 11 Phase 3 trial, which explores CagriSema's full potential for weight management in obesity, is anticipated in the first half of 2027. Furthermore, a Phase 3 trial for a higher-dose CagriSema is slated to commence in the latter half of 2026. This news comes after Novo Nordisk's February announcement of promising headline results from the REIMAGINE 2 Phase 3 trial, where CagriSema demonstrated superior HbA1c reduction and weight loss compared to semaglutide at 68 weeks across all tested doses.
This development underscores the highly competitive landscape within the weight-loss drug market. While Novo Nordisk faces a temporary setback, the company's commitment to further research and development with higher-dose formulations and ongoing trials suggests a resilient approach. Investors and patients alike will keenly watch the outcomes of these upcoming studies, as the quest for effective and safe weight-management solutions continues to drive pharmaceutical innovation.
