FDA Approves Higher-Dose Semaglutide for Weight Loss

The FDA has approved a higher dose of injectable semaglutide, marketed as Wegovy, for adults with obesity. The 7.2 mg dose is intended to lower excess body weight and help maintain weight reduction, building on the existing 2.4 mg Wegovy formulation approved in 2021. This approval follows positive results from the STEP UP and STEP UP T2D trials, demonstrating significant weight loss in participants receiving the higher dose.

Expanded Options for Weight Management

The approval of Wegovy 7.2 mg offers another tool for addressing obesity, a chronic health condition affecting millions. In the STEP UP trial, adults with obesity, but without type 2 diabetes, experienced an average weight loss of 20.7% over 72 weeks whereas taking the 7.2 mg dose of semaglutide. Notably, over 31% of participants in this trial lost 25% or more of their body weight during the same period. For individuals with both obesity and type 2 diabetes, the STEP UP T2D trial showed a 14.1% weight loss with the higher dose, and over 21% achieved at least a 20% reduction in body weight.

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. These medications operate by mimicking the effects of GLP-1, a natural hormone that regulates appetite and food intake. GLP-1 agonists can help people experience fuller for longer, leading to reduced calorie consumption. The FDA has recently issued warnings about unapproved versions of GLP-1 drugs, emphasizing the importance of obtaining medication through a prescription from a licensed healthcare provider and filling it at a state-licensed pharmacy.

Trial Details and Safety Profile

The STEP UP trial involved adults with obesity (BMI of 30 or greater) but without type 2 diabetes. Participants were randomly assigned to receive either semaglutide 7.2 mg or a placebo, in addition to lifestyle interventions focused on diet and exercise. The STEP UP T2D trial included individuals with both obesity and type 2 diabetes. Both trials demonstrated that the 7.2 mg dose of semaglutide resulted in significantly greater weight loss compared to placebo.

According to the press release from Novo Nordisk, the safety profile of semaglutide 7.2 mg was consistent with previous trials of the 2.4 mg dose. Common side effects associated with GLP-1 receptor agonists include nausea, vomiting, diarrhea, and constipation. These side effects are generally mild to moderate and tend to diminish over time. It’s important to note that semaglutide is not indicated for apply in individuals with a history of certain medical conditions, such as pancreatitis or medullary thyroid carcinoma.

From Shortage to Increased Access

The approval of Wegovy HD comes after a period of supply challenges for semaglutide products. As recently as February 2025, semaglutide was on the FDA’s drug shortage list, leading to compounded versions of the drug being created to fill gaps in access. However, with increased production by Novo Nordisk, the FDA resolved the shortage, and is now phasing out the allowance for compounding pharmacies to create their own versions. This shift aims to ensure patients have access to FDA-approved medications with verified safety, effectiveness, and quality.

Beyond Injection: The Rise of Oral Semaglutide

The expanded options for semaglutide don’t stop at a higher dose injection. In December 2023, the FDA approved Rybelsus, the first oral formulation of semaglutide, for weight loss. This provides a convenient alternative for individuals who prefer to take medication by mouth rather than injection. The availability of both injectable and oral formulations of semaglutide aims to broaden access and cater to diverse patient preferences.

Cardiometabolic Benefits and Future Directions

The benefits of semaglutide extend beyond weight loss. Studies have shown that semaglutide can also improve cardiometabolic health, reducing the risk of cardiovascular events in individuals with obesity. In March 2024, semaglutide 2.4 mg was approved to prevent cardiovascular events in people with overweight or obesity. Mike Doustdar, president and CEO of Novo Nordisk, highlighted the transformative impact of Wegovy, noting its ability to deliver “meaningful weight loss and important cardiometabolic benefits, including an unprecedented reduction in CV risk.”

Novo Nordisk plans to launch the 7.2 mg dose of semaglutide in a single-dose pen in April. The company’s continued investment in semaglutide research and development underscores its commitment to addressing the global obesity epidemic and improving patient outcomes. Further research is ongoing to explore the long-term effects of semaglutide and to identify individuals who may benefit most from this medication.

The FDA’s approval of Wegovy HD represents a significant step forward in the treatment of obesity. By providing a more potent dose of semaglutide, healthcare providers now have another option to help patients achieve substantial and sustained weight loss, potentially improving their overall health and quality of life. Individuals considering semaglutide should discuss the potential benefits and risks with their healthcare provider to determine if it is an appropriate treatment option for them.