FDA Approves High-Dose Semaglutide 7.2 mg for Obesity

The US Food and Drug Administration (FDA) has approved a higher dose of Novo Nordisk’s semaglutide (Wegovy; Wegovy HD) injection 7.2 mg for the treatment of obesity. The new offering is cleared for use alongside increased physical activity and a reduced calorie diet in persons with obesity who have tolerated the 2.4-mg Wegovy dose for at least 4 weeks and still require additional weight reduction, according to a March 19 press release.¹

The approval is supported by findings from the STEP UP clinical trial program, in which semaglutide 7.2 mg achieved a mean weight loss of 20.7% over 72 weeks in adults with obesity. Approximately one-third of participants achieved at least 25% weight loss, representing a clinically meaningful magnitude of effect for long-term obesity management.^1,2

"Wegovy® HD represents an important new tool in obesity management, allowing clinicians to better tailor treatment strategies and help improve outcomes," W Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham, said in a statement. "The weight loss demonstrated with Wegovy® HD could reshape healthcare professionals' expectations about what outcomes are possible for their patients with Wegovy®."¹

In a parallel phase 3 trial among individuals with obesity and type 2 diabetes, semaglutide 7.2 mg was associated with a mean weight loss of 14.1%. Across both studies, the safety and tolerability profile was consistent with prior semaglutide trials, with no new safety signals identified.^2,3

The FDA granted approval under the Commissioner’s National Priority Voucher program, which is intended to expedite therapies addressing significant public health needs. Novo Nordisk expects US availability beginning in April 2026 in a single-dose pen formulation, according to the press release.¹

"We are excited to bring Wegovy® HD injection to adults with obesity who are looking for powerful weight loss, as no other weight loss medicine has been studied to show superiority to Wegovy® HD," Jamey Millar, executive vice president, US Operations of Novo Nordisk, said in the press release. "In addition to significant weight loss, Wegovy® is the only GLP-1 for adults with obesity that is proven to reduce the risk of events such as stroke, heart attack, or cardiovascular death in those who also have known heart disease. Today's milestone expands the strong clinical profile of Wegovy® that includes multiple indications that no other GLP-1 for weight loss can claim."¹

References:

1. Novo Nordisk. FDA approves Novo Nordisk's new Wegovy® HD injection, delivering the highest weight loss to date for a Wegovy® injection, adding to its already expansive clinical profile. News release. March 19, 2026. Accessed March 19, 2026. https://www.prnewswire.com/news-releases/fda-approves-novo-nordisks-new-wegovy-hd-injection-delivering-the-highest-weight-loss-to-date-for-a-wegovy-injection-adding-to-its-already-expansive-clinical-profile-302718982.html
2. Halsey G. Semaglutide 7.2 mg Achieves Weight Reduction of 21% in Late-Stage STEP UP Trial. Patient Care Online. January 17, 2025. Accessed March 19, 2026. https://www.patientcareonline.com/view/semaglutide-7-2-mg-achieves-weight-reduction-of-21-in-late-stage-step-up-trial
3. Lingvay I, Bergenheim SJ, STEP UP T2D trial group, 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;13:935-948. doi:10.1016/S2213-8587(25)00225-6