Regulation

Novo Nordisk updates Singapore Wegovy label with higher-dose STEP UP data

Novo Nordisk's Singapore Wegovy label now includes data on a 7.2 mg dose that produced 20.7% average weight loss, but no US regulatory decision has been reported.

By the Semaglutides news desk··Wegovy
Novo Nordisk updates Singapore Wegovy label with higher-dose STEP UP data
Image: prnewswire.com

Novo Nordisk said on July 8, 2026 that Singapore updated the label for Wegovy (semaglutide) injection to include results from a trial of a higher 7.2 mg dose in adults with obesity who do not have diabetes [1]. The company said the change gives health care professionals in Singapore another option in obesity care, and did not say whether regulators in other countries, including the United States, are considering the same step [1].

The added evidence comes from STEP UP, a 72-week phase 3 trial that compared injectable semaglutide 7.2 mg with semaglutide 2.4 mg and with placebo, alongside lifestyle intervention. It enrolled about 1,400 adults with obesity but without diabetes [1].

Mean weight loss at 72 weeks was 20.7% on the "efficacy estimand," a measure that estimates the treatment effect if everyone stayed on their assigned treatment, and 18.7% on the "treatment-regimen estimand," which counts results regardless of whether people stayed on treatment [1]. The release also describes mean weight loss as "21%" in its summary bullets, a rounded version of the 20.7% figure [1].

On the strictest measure, 31.2% of patients on 7.2 mg lost at least 25% of their body weight, meaning about one in three reached that threshold and about two in three did not [1].

The company also published body-composition detail: up to 84% of the weight lost came from fat mass rather than lean tissue, according to the additional analyses [1]. Stephanie Ambrose, head of medical and regulatory affairs at Novo Nordisk Singapore, said in the release that "the conversation is shifting from simply how much weight is lost to how that weight is lost," pointing to fat-mass reductions alongside appetite control and eating behaviors [1].

A separate 72-week trial, STEP UP T2D, tested 7.2 mg against placebo in about 500 adults with obesity and type 2 diabetes. Mean weight loss was 14.1% on the efficacy estimand and 13.2% on the treatment-regimen estimand, and 21.3% of patients lost at least 20% of their body weight [1].

The release also says the trial showed a reduction in "sudden, impulsive loss of control when seeing or thinking about food," which the company says supports other real-world data about food noise, described as unwanted and intrusive thoughts about food [1].

Wegovy is indicated in Singapore for weight management in adults with a body mass index of 30 or higher, or 27 or higher with a weight-related condition, along with diet and exercise [1].

Why it matters for patients

The label change applies to Singapore. Whether the 7.2 mg dose will be submitted for review or approved by the US Food and Drug Administration has not been reported [1]. People in the US would continue to see the doses currently described on their labels.

Questions about whether GLP-1 weight loss comes from fat or muscle are common, and the body-composition figures address that only in part. The release reports the share of weight lost that was fat but does not give lean-mass numbers, so how much muscle was lost has not been disclosed [1].

The 25% weight-loss threshold is an unusually high bar. Fewer than one in three participants on 7.2 mg reached it, and the release does not break out results for people who lost less [1].

The release gives no rates of side effects, no information on how the higher dose was tolerated, and no pricing or insurance details for Singapore or any other market [1].

What happens next

The Singapore label update was announced on July 8, 2026 [1]. No dated milestones for regulatory submissions or decisions in the US or other countries were included in the release [1].

Sources

  1. https://www.prnewswire.com/apac/news-releases/wegovy-semaglutide-label-updated-in-singapore-with-higher-dose-supported-by-step-up-evidence-302820145.html

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