Novo Nordisk today presented the results from the phase 3b STEP UP trial in people with obesity without diabetes at the American Diabetes Association (ADA) Scientific Sessions, in Chicago, US. In the STEP UP trial, semaglutide 7.2 mg, the higher dose of Wegovy® demonstrated a mean weight loss of 21% with a third of participants losing 25% or more of their body weight compared to placebo at 72 weeks.1
“The STEP UP trial demonstrated that we can increase the dose of semaglutide and achieve greater weight loss than previously seen, and in line with semaglutide’s established safety profile. This may offer another option to people who do not attain their weight goals,” said Sean Wharton, lead study author and medical director of the Wharton Medical Clinic, Canada. “We are already aware that semaglutide can have health benefits for people with heart disease, liver disease, knee osteoarthritis, type 2 diabetes and prediabetes.These findings help to give patients with obesity more options for improvements in their weight and overall health.”
STEP UP co-primary endpointsat 72 weeks*1:
semaglutide 7.2 mg semaglutide 2.4 mg Placebo
Weight loss 20.7% 17.5% 2.4%
5% or more weight loss 93.2% 92.5% 35.7%
When evaluating the effect of treatment regardless of treatment adherence, people receiving semaglutide 7.2 mg achieved 18.7% weight loss vs 3.9% with placebo, and 90.7% achieved 5% or more weight loss with semaglutide 7.2 mg vs 36.8% on placebo.
“With these results, semaglutide reaffirms its significant weight loss for people with obesity. The STEP UP trial delivers a substantial weight loss of over 20%, in addition to health benefits previously demonstrated with semaglutide,” said Ludovic Helfgott, executive vice president of Product & Portfolio Strategy at Novo Nordisk. “As pioneers in obesity, we continue to develop new innovative treatments to fit the needs and preferences of people living with obesity. This includes maximising the value of semaglutide for individuals, healthcare systems and society, and developing a new oral formulation of Wegovy® that, pending FDA approval, can become the first GLP-1 pill to offer double-digit weight loss.”
In the STEP UP trial, semaglutide 7.2 mg demonstrated a well-tolerated safety profile consistent with previous Novo Nordisk semaglutide trials.1 The most common adverse events were gastrointestinal, and the vast majority were mild to moderate during dose escalation and diminished over time, consistent with the GLP-1 class.1 In STEP UP, 3.3% of people treated with semaglutide 7.2 mg discontinued due to gastrointestinal adverse events, compared to 2.0% with semaglutide 2.4 mg and 0% with placebo.1
Novo Nordisk expects to file the higher dose of Wegovy® for a label update in the EU in the second half of 2025, followed by regulatory submissions in other markets where Wegovy® is already approved.
STEP UP selected confirmatory secondary endpointsat 72 weeks*1:
semaglutide 7.2 mg semaglutide 2.4 mg Placebo
10% or more weight loss 86.0% 77.6% 20.0%
15% or more weight loss 70.4% 57.5% 7.9%
20% or more weight loss 50.9% 35.1% 2.9%
25% or more weight loss 33.2% 16.7% 0%
* Based on the trial product estimand: treatment effect if all people adhered to treatment.
