Novo Nordisk A/S: Wegovy® HD (semaglutide 7.2 mg) approved in the US, providing 20.7% mean weight loss
Summary by AI BETAClose X
- Wegovy® HD demonstrated a mean weight loss of 20.7%1, and around one-third of patients achieved 25% or greater weight loss in the STEP UP trial
- First US FDA approval of a GLP-1 treatment under the Commissioner’s National Priority Voucher pilot programme, for products addressing critical US national health priorities
- Wegovy® HD complements Wegovy® 2.4 mg, which is already approved in the US for weight management and cardiovascular risk reduction
- Novo Nordisk expects to launch Wegovy® HD in the US in April 2026
Bagsværd, Denmark, 19 March 2026 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Wegovy® HD (once-weekly injectable semaglutide 7.2 mg) to reduce excess body weight and maintain weight reduction long-term. The FDA awarded a Commissioner’s National Priority Voucher for Wegovy® HD, accelerating its review and underscoring its potential to address critical patient needs and national health priorities in the US.
The accelerated approval is based on results from the STEP UP trial programme. In the STEP UP trial, semaglutide 7.2 mg injected once weekly demonstrated 20.7%1 mean weight loss in participants with obesity, and approximately one in three people experienced 25% or greater weight loss. In the STEP UP type 2 diabetes (T2D) trial, in participants with obesity and type 2 diabetes, semaglutide 7.2 mg demonstrated a mean weight loss of 14.1%1. In both trials, the well-known safety and tolerability profile of semaglutide was reaffirmed with semaglutide 7.2 mg, which was comparable to previous trials with semaglutide for weight management.
“Since its launch in 2021, Wegovy® has transformed the lives of many people living with obesity and helped them achieve meaningful weight loss and important cardiometabolic benefits, including an unprecedented reduction in cardiovascular risk,” said Mike Doustdar, president and CEO of Novo Nordisk. “Earlier this year, we launched the Wegovy® pill, and with the accelerated approval of Wegovy® HD, we are introducing a new offering for our injectable semaglutide that provides even greater weight loss of approximately 21%. At Novo Nordisk, our goal is to provide innovative therapies that support healthier lives for people living with obesity, and we look forward to launching Wegovy® HD to help even more people reach their weight and health goals.”
Novo Nordisk expects to launch Wegovy® HD in a single-dose pen in the US in April 2026.
Wegovy® 7.2 mg is already approved for adults with obesity in the EU and the UK. Novo Nordisk expects regulatory decisions in the EU and the UK on semaglutide 7.2 mg in a single-dose pen in the second half of 2026.
About the STEP UP trials
The STEP UP and STEP UP T2D phase 3 trials investigated the efficacy and safety of injectable semaglutide 7.2 mg in people with obesity with or without type 2 diabetes.
The 72-week STEP UP trial evaluated the efficacy and safety of injectable semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo as an adjunct to lifestyle intervention. The trial included approximately 1,400 adults with obesity. The 72-week STEP UP T2D trial evaluated the efficacy and safety of injectable semaglutide 7.2 mg compared to placebo in approximately 500 adults with obesity and type 2 diabetes.
| Mean weight loss at 72 weeks with semaglutide 7.2 mg in STEP UP trials | ||
| STEP UP | STEP UP T2D | |
| Efficacy estimand* | 20.7% | 14.1% |
| Treatment-regimen estimand** | 18.7% | 13.2% |
| Categorical weight loss | 31.2% of patients achieved ≥25% weight loss | 21.3% of patients achieved ≥20% weight loss |
* Treatment effect if all people adhered to treatment, ** Treatment effect regardless of treatment adherence
About Wegovy®
Wegovy® is approved as once-daily Wegovy® pill (semaglutide tablet 25 mg) and once-weekly Wegovy® injections (semaglutide 1.7 mg, 2.4 mg and 7.2 mg) by the FDA.
Wegovy® is approved as a once-weekly injection by the EMA and by other regulatory authorities worldwide. The Wegovy® pill is currently pending marketing approval from the EMA and other regulatory authorities.
Wegovy® is indicated to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight and in the presence of at least one weight-related comorbid condition, and approved by the FDA to reduce the risk of major adverse cardiovascular events, such as death, heart attack or stroke in adults with known heart disease and either obesity or overweight. Furthermore, Wegovy® injection is indicated to reduce excess body weight and maintain long-term weight reduction in paediatric patients aged 12 years and older. It is approved by the FDA for the treatment of MASH in adults with moderate to advanced liver scarring (fibrosis), but not in those with cirrhosis of the liver.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 68,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.
Publication of inside information pursuant to Market Abuse Regulation, Article 17.
Contacts for further information
| Novo Nordisk Media: | |
| Ambre James-Brown +45 3079 9289 globalmedia@novonordisk.com | Liz Skrbkova (US) +1 609 917 0632 lzsk@novonordisk.com |
| Novo Nordisk Investors: | |
| Michael Novod +45 3075 6050 nvno@novonordisk.com | Jacob Martin Wiborg Rode +45 3075 5956 jrde@novonordisk.com |
| Sina Meyer +45 3079 6656 azey@novonordisk.com | Max Ung +45 3077 6414 mxun@novonordisk.com |
| Christoffer Sho Togo Tullin +45 3079 1471 cftu@novonordisk.com | Alex Bruce +45 3444 2613 axeu@novonordisk.com |
| Frederik Taylor Pitter +1 609 613 0568 fptr@novonordisk.com |
Company announcement No 19 / 2026
1 Based on the efficacy estimand: treatment effect if all people adhered to treatment
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