Novo Nordisk "wins by volume": High-dose semaglutide trial shows 19% weight loss effect, but still lags behind Lilly’s competing product.

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Recently, Novo Nordisk announced results of a clinical trial, showing that its much-anticipated Semaglutide demonstrated more significant weight loss effects when the dosage was tripled.

Semaglutide is Novo Nordisk’s flagship product, marketed under the brands Wegovy for weight loss and Ozempic for diabetes. In two recent phase 3 clinical trials, researchers tested a 7.2 mg dose of Semaglutide, while the currently approved maximum dose is 2.4 mg.

In the larger of the two trials, patients lost an average of 19% of their body weight after 72 weeks. By comparison, those using the standard 2.4 mg dose lost an average of 16%, while the placebo group lost only 4%.

However, these results still fall short of the market leader Eli Lilly’s tirzepatide. Eli Lilly’s drug is sold under the brands Zepbound and Mounjaro; in trials with its highest approved dose, average weight loss reached as high as 22.5%.

High Dose Regimen Shows Notable Gain, But Still Lags Behind Eli Lilly

While it does not lead at peak efficacy, the new higher dose option is still seen as clinically meaningful.

Naveed Sattar, Professor of Metabolic Medicine at the University of Glasgow, pointed out that this kind of “incremental” benefit is still clinically important, especially considering that the price of high-dose tirzepatide from Eli Lilly has risen sharply in some regions. He believes:

“If pricing is competitive, the 7.2 mg dose of Semaglutide will be a more affordable option.”

Although this trial data brings new incremental potential for Semaglutide, Novo Nordisk has recently faced a number of challenges in the market. The company has lost market share in the US to Eli Lilly and “combination” generics, its stock price has dropped by 60% in the past year, it changed its CEO in May, and recently announced plans to lay off 9,000 employees.

Safety is Manageable but Side Effects Increase with Dosage

While efficacy increases, the occurrence of side effects also rises accordingly. Trial data shows that about 71% of participants on the 7.2 mg dose experienced gastrointestinal symptoms, compared to 61% in the current dose group. In addition, over one-fifth of the high-dose group experienced paresthesia (skin sensation changes, sometimes accompanied by pain), which usually requires a temporary dose reduction.

The trials, named STEP-UP and STEPUPT2D, were the first to verify whether tripling the dose of Semaglutide could yield greater weight loss effects. In the STEP-UP study, which included about 1,400 obese adults, nearly half of those on the 7.2 mg dose lost more than 20% of their body weight, and one-third lost at least 25%.

In another smaller trial focusing on obese patients with type 2 diabetes, the high-dose group lost 13% of their body weight, the standard dose group 10%, and the placebo group 4%. Both studies showed improvements in participants’ health metrics, including waist circumference, blood pressure, cholesterol, and blood sugar levels.

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