At a Glance
- EU Approval: Wegovy® 7.2 mg weekly for obesity after 2.4 mg (CHMP Dec 2025).
- Dosing: Three 2.4 mg injections weekly; 7.2 mg pen pending. UK approved; FDA pending.
- STEP UP (NCT05646706): 21% weight loss (1,407 non-diabetics); 84% fat mass.
- STEP UP T2D (NCT05649137): Superior loss in 512 with T2D; mild GI side effects
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
Novo Nordisk has announced that the European Commission has greenlit a new 7.2 mg once-weekly maintenance dose of Wegovy® (semaglutide injection) for adults with obesity. This approval, following a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on December 12, 2025, offers physicians an additional tool for patients who require greater weight loss after reaching the standard 2.4 mg dose.
New Dosing Flexibility in the EU
In the European Union, clinicians can now prescribe the 7.2 mg dose administered as three 2.4 mg injections in one weekly sitting for adults who have been on Wegovy® 2.4 mg for at least four weeks and need intensified treatment.
This step-up approach aims to boost weight loss while helping preserve muscle function. Novo Nordisk has submitted an application for a dedicated 7.2 mg single-dose pen, which, if approved, could launch in the EU this year.
The 7.2 mg dose is already approved and available in the UK, with regulatory filings pending at the US Food and Drug Administration (FDA) and in several other countries.
Wegovy® injectable now comes in EU doses of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg. (Note: An oral Wegovy® formulation is available in the US and under review in the EU.)
Key Findings from STEP UP Clinical Trials
The approval based on data from two phase 3 trials: STEP UP (NCT05646706) (1,407 adults with obesity but without type 2 diabetes) and STEP UP T2D (NCT05649137) (512 adults with obesity and type 2 diabetes). Participants received the 7.2 mg dose weekly alongside lifestyle interventions (reduced-calorie diet and increased physical activity) and were compared to placebo groups.
In the non-diabetic cohort:
- Those on Wegovy® 7.2 mg achieved an average 21% body weight loss (per-protocol analysis) versus about 2% on placebo.
- Roughly one in three participants lost 25% or more of their body weight.
- Body composition benefits included 84% of weight loss from fat mass, with muscle function preserved based on testing.
Side effects were mostly mild to moderate and short-lived, with the most common being gastrointestinal issues nausea, diarrhea, and vomiting (24.8% incidence) followed by dysaesthesia (22-29%).
Broader Indications and Expert Perspective
Wegovy® is indicated in the EU as an adjunct to diet and exercise for weight management in adults with BMI ≥30 kg/m² (obesity) or BMI ≥27 kg/m² (overweight) plus at least one weight-related comorbidity.
It also covers adolescents aged 12+ with obesity (BMI ≥95th percentile for age/gender and weight >60 kg). Label data highlight cardiovascular risk reduction, improvements in heart failure with preserved ejection fraction (HFpEF) symptoms, physical function, and knee osteoarthritis pain relief.
“This approval marks a key advancement in obesity care, providing healthcare professionals greater flexibility to personalize treatment and support substantial weight loss,” said Emil Kongshøj Larsen, Executive Vice President of International Operations at Novo Nordisk.
This development underscores ongoing innovations in GLP-1 receptor agonist therapies, offering hope for better outcomes in obesity management.
Reference
Novo Nordisk A/S: The European Commission approves more effective dose of injectable Wegovy® for adults with obesity; clinical study showed people lost about 21% of their body weight on average, 17 February 2026, News Details
A Research Study to See How Semaglutide Helps People with Excess Weight, Lose Weight (STEP UP) (STEP UP), ClinicalTrials.gov ID NCT05646706, https://clinicaltrials.gov/study/NCT05646706
Wharton S et al, Once-weekly semaglutide 7·2 mg in adults with obesity (STEP UP): a randomised, controlled, phase 3b trial. Lancet Diabetes Endocrinol. 2025 Nov;13(11):949-963. Epub 2025 Sep 14. PMID: 40961952. https://doi.org/10.1016/s2213-8587(25)00226-8
A Research Study to See How Semaglutide Helps People with Excess Weight and Type 2 Diabetes Lose Weight, ClinicalTrials.gov ID NCT05649137, https://clinicaltrials.gov/study/NCT05649137
Lingvay I et al, Once-weekly semaglutide 7·2 mg in adults with obesity and type 2 diabetes (STEP UP T2D): a randomised, controlled, phase 3b trial. Lancet Diabetes Endocrinol. 2025 Nov;13(11):935-948. Epub 2025 Sep 14. PMID: 40961953. https://doi.org/10.1016/s2213-8587(25)00225-6