Jul 09, 2025
WEGOVY (semaglutide 2.4 mg) is already approved in the EU and the US as part of a comprehensive weight management approach. At the 2025 ADA Scientific Sessions in Chicago, Novo Nordisk presented new data from the Phase IIIb STEP UP program, spotlighting the potential of a higher 7.2 mg dose of semaglutide in individuals with obesity, both with and without T2D.
ADA 2025 Coverage: STEP UP Trial Establishes Semaglutide 7.2 mg as a New Benchmark in Obesity Management
In the 72-week STEP UP trial, which enrolled 1,407 adults with obesity (BMI ≥30 kg/m²) but without diabetes, semaglutide 7.2 mg led to a mean body weight reduction of 21%, with nearly one-third of participants losing ≥25% of their body weight—a magnitude of loss that approaches bariatric-level outcomes. In comparison, semaglutide 2.4 mg, the currently approved dose, and placebo achieved significantly lower reductions, underscoring the enhanced efficacy of the 7.2 mg formulation.
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Notably, in intention-to-treat analyses, patients on semaglutide 7.2 mg experienced an average weight loss of 18.7%, compared to just 3.9% with placebo. Additionally, over 90% of participants on the higher dose achieved ≥5% weight loss, compared to 36.8% on placebo, meeting all key secondary endpoints, including thresholds for ≥10%, 15%, 20%, and 25% weight loss.
| STEP UP Co-primary Endpoints at 72 Weeks | |||
| 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% |
| STEP UP Selected Confirmatory Secondary Endpoints at 72 Weeks | |||
| 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% |
A parallel trial, STEP UP T2D, evaluated semaglutide 7.2 mg in 512 adults with obesity and T2D, further demonstrating its efficacy across diverse metabolic populations.
The safety profile of semaglutide 7.2 mg was consistent with that of the GLP-1 class, with gastrointestinal events being the most commonly reported adverse effects. These were largely mild to moderate, occurred during dose escalation, and declined over time. Discontinuation rates due to GI events were 3.3% with 7.2 mg, 2.0% with 2.4 mg, and 0% with placebo, indicating a manageable tolerability profile for the higher dose.
KOL Views
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. – Expert Opinion
The STEP UP trial showed that increasing the dose of semaglutide can lead to greater weight loss than previously observed while maintaining its well-established safety profile, potentially providing an additional option for individuals who do not reach their weight loss targets with the current dose. – Expert Opinion
Conclusion
The STEP UP data elevate semaglutide 7.2 mg to the forefront of next-generation obesity pharmacotherapy, signaling a clear move toward bariatric-level efficacy in an injectable formulation. With a well-characterized safety profile and consistent benefits across both nondiabetic and diabetic populations, this higher dose strengthens Novo Nordisk’s competitive moat in the obesity market. The impressive weight loss seen underscores the potential of 7.2 mg semaglutide to capture unmet demand among patients plateauing on current doses or seeking more aggressive outcomes without surgery. With EU filing planned for H2 2025 and broader global submissions expected, this label expansion could further consolidate WEGOVY’s market leadership and expand its addressable patient base across primary and specialty care.
Article in PDF
Jul 09, 2025
WEGOVY (semaglutide 2.4 mg) is already approved in the EU and the US as part of a comprehensive weight management approach. At the 2025 ADA Scientific Sessions in Chicago, Novo Nordisk presented new data from the Phase IIIb STEP UP program, spotlighting the potential of a higher 7.2 mg dose of semaglutide in individuals with obesity, both with and without T2D.
ADA 2025 Coverage: STEP UP Trial Establishes Semaglutide 7.2 mg as a New Benchmark in Obesity Management
In the 72-week STEP UP trial, which enrolled 1,407 adults with obesity (BMI ≥30 kg/m²) but without diabetes, semaglutide 7.2 mg led to a mean body weight reduction of 21%, with nearly one-third of participants losing ≥25% of their body weight—a magnitude of loss that approaches bariatric-level outcomes. In comparison, semaglutide 2.4 mg, the currently approved dose, and placebo achieved significantly lower reductions, underscoring the enhanced efficacy of the 7.2 mg formulation.
Notably, in intention-to-treat analyses, patients on semaglutide 7.2 mg experienced an average weight loss of 18.7%, compared to just 3.9% with placebo. Additionally, over 90% of participants on the higher dose achieved ≥5% weight loss, compared to 36.8% on placebo, meeting all key secondary endpoints, including thresholds for ≥10%, 15%, 20%, and 25% weight loss.
| STEP UP Co-primary Endpoints at 72 Weeks | |||
| 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% |
| STEP UP Selected Confirmatory Secondary Endpoints at 72 Weeks | |||
| 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% |
A parallel trial, STEP UP T2D, evaluated semaglutide 7.2 mg in 512 adults with obesity and T2D, further demonstrating its efficacy across diverse metabolic populations.
The safety profile of semaglutide 7.2 mg was consistent with that of the GLP-1 class, with gastrointestinal events being the most commonly reported adverse effects. These were largely mild to moderate, occurred during dose escalation, and declined over time. Discontinuation rates due to GI events were 3.3% with 7.2 mg, 2.0% with 2.4 mg, and 0% with placebo, indicating a manageable tolerability profile for the higher dose.
KOL Views
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. – Expert Opinion
The STEP UP trial showed that increasing the dose of semaglutide can lead to greater weight loss than previously observed while maintaining its well-established safety profile, potentially providing an additional option for individuals who do not reach their weight loss targets with the current dose. – Expert Opinion
Conclusion
The STEP UP data elevate semaglutide 7.2 mg to the forefront of next-generation obesity pharmacotherapy, signaling a clear move toward bariatric-level efficacy in an injectable formulation. With a well-characterized safety profile and consistent benefits across both nondiabetic and diabetic populations, this higher dose strengthens Novo Nordisk’s competitive moat in the obesity market. The impressive weight loss seen underscores the potential of 7.2 mg semaglutide to capture unmet demand among patients plateauing on current doses or seeking more aggressive outcomes without surgery. With EU filing planned for H2 2025 and broader global submissions expected, this label expansion could further consolidate WEGOVY’s market leadership and expand its addressable patient base across primary and specialty care.
