Novo Nordisk's High-Dose Wegovy Shows Promising Results in Phase III Trial, Intensifying Competition with Eli Lilly

Novo Nordisk has reported positive results from its Phase III STEP UP trial, evaluating a high-dose formulation of its popular weight loss drug Wegovy (semaglutide). The study, which tested a 7.2 mg dose of semaglutide against the currently approved 2.4 mg dose and placebo, demonstrated superior weight loss outcomes that could potentially narrow the efficacy gap with Eli Lilly's rival drug, Zepbound.

STEP UP Trial Results

In the 72-week trial involving 1,407 adults with obesity but without diabetes, patients receiving the 7.2 mg dose of semaglutide experienced an average weight loss of 18.7% of their body weight. This compares favorably to the 15.6% weight loss observed in the 2.4 mg group and 3.9% in the placebo group. Notably, one-third of patients on the high dose lost at least 25% of their weight, compared to 16.7% of those on the lower dose.

Martin Holst Lange, Executive Vice President of Development at Novo Nordisk, expressed satisfaction with the results, stating, "We are very pleased to demonstrate 20.7% weight loss and to see that 33% of patients achieved more than 25% weight loss with semaglutide 7.2 mg, with a safety and tolerability profile comparable to semaglutide 2.4 mg."

The safety profile of the 7.2 mg dose appeared to be consistent with the known profile of semaglutide, with the most common adverse events being gastrointestinal in nature, typically mild to moderate and diminishing over time.

Competitive Landscape

The results from the STEP UP trial come at a crucial time for Novo Nordisk, as it faces increasing competition from Eli Lilly's Zepbound (tirzepatide). In December, Lilly reported that Zepbound outperformed Wegovy in a head-to-head Phase IIIb trial called SURMOUNT-5, where patients on Zepbound lost an average of 20.2% of their body weight over 72 weeks.

While cross-trial comparisons can be misleading, the new high-dose Wegovy results suggest that Novo Nordisk may be closing the efficacy gap with Lilly's offering. However, analysts from Leerink Partners noted that historical data showed better cross-trial tolerability for tirzepatide compared to semaglutide's 2.4 mg dose, highlighting the need for detailed safety and tolerability data from the STEP UP trial.

Future Implications and Market Dynamics

Novo Nordisk plans to share detailed results from the STEP UP trial at an upcoming medical conference. The company is also conducting a separate Phase III study, STEP UP T2D, evaluating the 7.2 mg dose in adults with Type 2 diabetes and obesity, with results expected in the coming months.

The positive data from the high-dose Wegovy trial coincides with the announcement that the Centers for Medicare and Medicaid Services has selected semaglutide for its second cycle of price negotiations. This development could potentially lower the price the government pays for both Wegovy and Ozempic (the diabetes brand of semaglutide) starting in 2027.

As the competition in the GLP-1 receptor agonist market intensifies, both Novo Nordisk and Eli Lilly continue to invest in expanding their product offerings and improving efficacy. The ongoing developments in this therapeutic area are likely to have significant implications for the treatment of obesity and related metabolic disorders in the coming years.