TIDES Express | Novo Nordisk Submits Application for 7.2 mg Semaglutide for Weight Management

Jul 10, 2025 09:10 CST Updated 09:10

Novo Nordisk

Insulin Developer and Manufacturer

｜Edited by the Content Team of Zhong Peptide Biochemical

2025Year 7, Month 8DayNovo Nordisk announces that the marketing application for 7.2mg semaglutide has been accepted by the European Medicines Agency (EMA) for weight management.

This marketing application is based onPhase III STEP UP Study and Phase IIIPositive Results from the STEP UP T2D Study.

The STEP UP study included1407 casesBMI≥30kg/m²TheWithout DiabetesAdult patients with obesity,EvaluatedSemaglutide (7.2mg,Once a week),Semaglutide (2.4mg,Weekly 1Times)Compared with the placebo in terms of weight loss effects and safety. The primary endpoints of the study were the percentage change in body weight from baseline at week 72 and the proportion of patients with at least a 5% reduction in body weight.

The results showed that at Week 72 of treatment, 7.2mgPatients in the semaglutide group experienced greater weight loss than those in the placebo group, and the data was statistically significant.. The specific situation is as follows:

From the perspective of treatment efficacy (All patientsPersist in Treatment) Evaluation:The average baseline weight of the patients was 113 kg.7.2mg Semaglutide Group, 2.4mg semaglutide group and placebo groupThe patients' weight decreased respectively.20.7%, 17.5%, and 2.4%. In addition,7.2mg Semaglutide GroupThere is33.2% of patients achieved a weight loss of more than 25%., while 2.4mgSemaglutide GroupThe proportions in the placebo group were 16.7% and 0.0%, respectively.
From the perspective of treatment strategiesDegree (Regardless of whether the patientPersist in Treatment）Evaluation：The weight of patients in the 7.2mg semaglutide group, 2.4mg semaglutide group, and placebo group decreased respectively.18.7%, 15.6%, and 3.9%。

In terms of safety,7.2mgSemaglutide in the studyDemonstrated good safety and tolerability. The most common adverse events were gastrointestinal adverse events, the vast majority of which were mild to moderate and decreased over time, consistent with the characteristics of GLP-1 receptor agonists observed in previous studies.

The STEP UP T2D study included512 casesBMI≥30kg/m²TheWith DiabetesAdult patients with obesity,EvaluatedSemaglutide (7.2mg,Once a week),Semaglutide (2.4mg,Once a weekTime(s)Compared with the placebo in terms of weight loss effects and safety. The primary endpoints of the study were the percentage change in body weight from baseline at week 72 and the proportion of patients with at least a 5% reduction in body weight.

The results showed that at Week 72 of treatment, 7.2mgPatients in the semaglutide group experienced greater weight loss than those in the placebo group, with statistically significant data.。The specific situation is as follows:

From the perspective of treatment efficacy (all patients adhered to the treatment): the average baseline weight of the patients was 110kg. The 7.2mg semaglutide group, 2.4mg semaglutide group and placebo groupThe patients' weight decreased respectively.14.1%, 10.7%, and 3.6%。Moreover, 89.7% of patients in the 7.2mg semaglutide group achieved a weight loss of more than 5%, compared to 78.3% in the 2.4mg semaglutide group and 33.3% in the placebo group.

From the perspective of treatment strategy (regardless of whether patients adhere to the treatment): 7.2mg semaglutide group, 2.4mg semaglutide group and placebo groupThe patients' weight decreased respectively13.2%, 10.4%, and 3.9%。Moreover, 86.3% of patients in the 7.2mg semaglutide group achieved a weight loss of more than 5%, compared to 75.3% in the 2.4mg semaglutide group and 34.7% in the placebo group.

About Semaglutide

Semaglutide is a GLP-1 receptor agonist that stimulates insulin production, inhibits glucagon secretion, and reduces appetite and food intake. Semaglutide was initially developed as a treatment for type 2 diabetes.ApprovedLaunched (Brand name: Ozempic), in view of its significant effect on weight loss, the FDA in June 2021ApprovalIt is used to treat ordinary obese patients (trade name: Wegovy), which is the first new drug approved by the US FDA for controlling common obesity or overweight since 2014. The drug was subsequently approved by the EU for the treatment of obesity indications later in the same year.

AboutNovo Nordisk

Novo Nordisk, founded in 1923, is a global leading biopharmaceutical company headquartered in Copenhagen, the capital of Denmark. Our goal is to drive change to defeat diabetes and other serious chronic diseases such as obesity, rare blood disorders, and endocrine disorders. To achieve this goal, we lead scientific breakthroughs, expand the accessibility of our medicines, and are committed to preventing and ultimately curing these diseases. Novo Nordisk has approximately 47,000 employees across 80 countries and regions worldwide, providing products and services to more than 168 countries and regions globally.

Source:

1. PharmaCube