Novo Nordisk publishes full STEP UP body composition detail with a Singapore label update

Novo Nordisk has published complete body composition results from its STEP UP trial of a higher dose of semaglutide, the drug sold as Wegovy, alongside a label update in Singapore that incorporates the new data ^[1]. The update applies only to Singapore's regulatory label for now. The trial tested a 7.2 mg dose of semaglutide, which is higher than the 2.4 mg maximum dose currently approved in most markets, including the United States ^[1].

In the 72-week STEP UP trial, which enrolled about 1,400 adults with obesity but without diabetes, participants on the 7.2 mg dose lost an average of 20.7% of their body weight under the "efficacy estimand," a statistical measure that reflects what happens when people stick with treatment as prescribed ^[1]. Under a separate measure that accounts for people who did not fully adhere to treatment, called the "treatment-regimen estimand," average weight loss was 18.7% ^[1]. About 31.2% of participants lost at least a quarter of their body weight over the 72 weeks ^[1].

A companion trial, STEP UP T2D, tested the same 7.2 mg dose in roughly 500 adults with obesity and type 2 diabetes. Weight loss was smaller in this group: 14.1% under the efficacy estimand and 13.2% under the treatment-regimen estimand, with 21.3% of patients reaching at least 20% weight loss ^[1]. This gap between people with and without diabetes has shown up in earlier semaglutide and tirzepatide trials as well, and it appeared again here.

Beyond the raw percentages, Novo Nordisk emphasized what made up the weight loss. Additional analyses found that fat mass accounted for up to 84% of the weight participants lost on the 7.2 mg dose ^[1]. The company also reported that the trial showed a reduction in what it described as "sudden, impulsive loss of control when seeing or thinking about food," which it linked to broader real-world reports of reduced "food noise" among people taking semaglutide ^[1].

Why it matters for patients

For people already taking or considering semaglutide, the composition of weight loss matters as much as the total amount. Losing more weight from fat rather than lean tissue like muscle is generally considered a marker of healthier weight loss, since muscle loss can affect strength and metabolism over time ^[1]. Novo Nordisk's Stephanie Ambrose, head of medical and regulatory affairs in Singapore, said the conversation in obesity care is "shifting from simply how much weight is lost to how that weight is lost" ^[1].

However, this specific 7.2 mg dose is not yet approved in the United States. The Singapore label change is a regulatory action in that country only, based on the STEP UP evidence ^[1]. American patients currently using Wegovy are prescribed doses up to 2.4 mg, and the sources provided do not say when or whether a higher-dose version might be reviewed by the US Food and Drug Administration. That timeline is not yet known from available information.

The data also show that people with type 2 diabetes lost meaningfully less weight than those without diabetes in this same trial program, a pattern that has practical implications for how results might vary based on an individual's underlying health conditions ^[1].

What happens next

The sources do not include a timeline for regulatory review of the 7.2 mg dose in the United States or other major markets beyond Singapore. It is not yet known when or if Novo Nordisk will seek similar label changes elsewhere, including through the FDA.