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Press release
Thu, 19 Mar 2026 12:04:00 -0400
Thu, 19 Mar 2026 12:04:00 -0400
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
- Average weight loss of ~21% at 72 weeks in adults with obesity if all patients stayed on treatment* with Wegovy® HD (~19% regardless of whether patients stayed on treatment**) in the STEP UP trial1
- In the STEP UP trial, about one in three trial participants taking Wegovy® HD achieved 25% weight loss or higher1
- This approval for Wegovy® further expands its already robust label inclusive of multiple formulations, including Wegovy® pill, and indications not available with other GLP-1 weight loss medicines
PLAINSBORO, N.J., March 19, 2026 /PRNewswire/ -- Novo Nordisk today announced US Food and Drug Administration (FDA) approval of a new higher dose of Wegovy®, Wegovy® HD (semaglutide) injection 7.2 mg, which demonstrated substantial weight loss in adults with obesity in the STEP UP trial.1,2 Wegovy® HD can be used along with a reduced calorie diet and increased physical activity to help adults with obesity lose weight and keep it off, provided they have tolerated the 2.4 mg dosage for at least 4 weeks and additional weight reduction is clinically indicated. This new update supplements the existing Wegovy® label, which also has distinct indications for Wegovy® not offered by any other GLP-1 medication for weight loss.2
“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,” said Jamey Millar, executive vice president, US Operations of Novo Nordisk. “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.”
Prior to this approval, the highest approved dose of Wegovy® injectable for weight loss was 2.4 mg, which is also indicated, along with a reduced calorie diet and increased physical activity, to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight.2
The FDA approval of Wegovy® HD is based on the results of the STEP UP trial program, which included STEP UP, a 72-week study which evaluated the efficacy and safety of once-weekly Wegovy® 7.2 mg compared to placebo and Wegovy® 2.4 mg, as an adjunct to lifestyle intervention in 1,407 adults with obesity (BMI 30 kg/m2 or greater), without diabetes.1,3
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STEP UP Trial Results (at 72 weeks¹, ²) |
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Wegovy® injection 7.2 mg |
Wegovy® injection 2.4 mg |
Placebo |
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Average weight reduction¹ |
If all patients stayed on treatment
(Efficacy estimand*) |
~21% (20.7%) |
~18% (17.5%) |
~2% (2.4%) |
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Analysis of all patients regardless of if they stayed on treatment²
(Treatment regimen estimand**) |
~19% (18.8%) |
~16% (15.5%) |
~4% (3.9%) |
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Percent of patients who achieved 25% or more weight loss** |
31.2% |
15.3% |
0% |
Based on a mean baseline body weight of 248 lb. for Wegovy® injection 7.2 mg and placebo groups, and 257 lb. for the Wegovy® 2.4 mg group.
The most common adverse reactions reported with Wegovy® HD were nausea, vomiting, dysesthesia, constipation, abdominal pain, fatigue, headache, dizziness, hair loss and flatulence. In clinical trials, dysesthesia was reported at a higher rate with Wegovy® HD compared to Wegovy® 2.4 mg and placebo.2 Events related to a clinical picture of altered skin sensation such as sensitive skin, hyperesthesia, dysesthesia and paresthesia were reported by a higher proportion of participants, and at a higher rate, in the Wegovy® HD arm (22%), compared to treatment with Wegovy® 2.4 mg (6%) and placebo (0.3%).2
“Wegovy® HD represents an important new tool in obesity management, allowing clinicians to better tailor treatment strategies and help improve outcomes,” said W. Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham. “The weight loss demonstrated with Wegovy® HD could reshape healthcare professionals’ expectations about what outcomes are possible for their patients with Wegovy®.”
Wegovy® HD will be available in April through all channels where patients can access Wegovy® including 70,000 plus pharmacies in the US like CVS and Costco, select telehealth providers, NovoCare® Pharmacy, GoodRx, and others. Additional information on coverage and savings options for eligible patients, including other programs designed to help reduce out-of-pocket costs, will also be available at that time.
* Based on the efficacy estimand: estimated efficacy in an idealized scenario in which all patients stayed on treatment and took no other weight loss therapies.
** Based on the treatment regimen estimand: treatment effect regardless of whether patients stayed on treatment or took other weight loss therapies.
About the STEP UP trial
STEP UP was a phase 3b 72-week randomized, double-blinded, placebo-controlled and active-controlled superiority trial designed to evaluate the efficacy and safety of semaglutide injection 7.2 mg compared to semaglutide injection 2.4 mg and placebo as an adjunct to lifestyle intervention.1 1,407 adults with BMI ≥30 kg/m2 without diabetes were included in the trial. The primary objective was to demonstrate superiority of semaglutide 7.2 mg against placebo on weight loss after 72 weeks with respect to the percentage change in body weight and the proportion of participants achieving weight loss of 5% or greater.1 Select confirmatory secondary endpoints included number of participants achieving ≥10%, 15%, 20% and 25% weight loss, with semaglutide 7.2 mg vs placebo (and for greater than or equal to 20% and 25%, semaglutide 7.2 mg vs semaglutide 2.4 mg).1 In total, 1,407 participants were randomized in a 5:1:1 ratio to receive once-weekly subcutaneous semaglutide 7.2 mg, 2.4 mg, or placebo, alongside lifestyle intervention, for 72 weeks.1 For those taking Wegovy® HD, 89% achieved 5% or greater body weight loss versus 38% taking placebo (from a baseline body weight of 248 lb.).**
About obesity
Obesity is a serious, chronic, progressive, and complex disease that requires long-term management.4-6 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.4,6 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.7,8
What is Wegovy®?
Wegovy® (semaglutide) injection is a prescription medicine used with a reduced-calorie diet and increased physical activity to:
- reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight.
- help adults and children aged 12 years and older with obesity, or some adults with excess weight (overweight) who also have weight-related medical problems to lose weight and keep the weight off.
Wegovy® (semaglutide) tablets are a prescription medicine used with a reduced-calorie diet and increased physical activity to:
- reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight.
- help adults with obesity, or some adults with excess weight (overweight) who also have weight-related medical problems to lose weight and keep the weight off.
Wegovy® contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines.
It is not known if Wegovy® injection is safe and effective:
- to reduce the risk of major cardiovascular events (death, heart attack, or stroke) in people under 18 years
- to help children under 12 years of age lose weight and keep the weight off
It is not known if Wegovy® tablets are safe and effective for use in people under 18 years of age.
Important Safety Information
What is the most important information I should know about Wegovy®?
Wegovy® may cause serious side effects, including:
- Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Wegovy® and other medicines that work like Wegovy® caused thyroid tumors, including thyroid cancer. It is not known if Wegovy® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people
- Do not use Wegovy® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
Do not use Wegovy® if:
- you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy® injection or Wegovy® tablets. See symptoms of serious allergic reaction in “What are the possible side effects of Wegovy®?”
Before using Wegovy®, tell your healthcare provider if you have any other medical conditions, including if you:
- have or have had problems with your pancreas or kidneys
- have type 2 diabetes and a history of diabetic retinopathy
- are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)
- are pregnant or plan to become pregnant. Wegovy® may harm your unborn baby. You should stop using Wegovy® 2 months before you plan to become pregnant
- are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with Wegovy® tablets. It is not known if Wegovy® when received through an injection passes into your breast milk
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy® may affect the way some medicines work and some medicines may affect the way Wegovy® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy® slows stomach emptying and can affect medicines that need to pass through the stomach quickly.
What are the possible side effects of Wegovy®?
Wegovy® may cause serious side effects, including:
- inflammation of your pancreas (pancreatitis). Stop using Wegovy® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back
- gallbladder problems. Wegovy® may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools
- increased risk of low blood sugar (hypoglycemia), especially those who also take medicines for diabetes such as insulin or sulfonylureas. This can be a serious side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy®. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery
- dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away
- severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Wegovy®. Tell your healthcare provider if you have stomach problems that are severe or will not go away
- serious allergic reactions. Stop using Wegovy® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat
- change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy®
- increased heart rate. Wegovy® can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes
- food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Wegovy® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Wegovy® before you are scheduled to have surgery or other procedures
The most common side effects of Wegovy® may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, changes in skin sensations, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, low blood sugar in people with type 2 diabetes, gas, stomach flu, heartburn, and hair loss.
Please click here for Prescribing Information including Boxed Warning and Medication Guide for Wegovy®.
About Novo Nordisk
Novo Nordisk is a leading global health care company that’s been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs approximately 10,000 people across more than 10 manufacturing, R&D and corporate locations in eight states plus Washington, D.C. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.
Contacts for further information
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Media: |
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Liz Skrbkova (US)
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Ambre James-Brown (Global)
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Investors: |
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Frederik Taylor Pitter (US)
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Michael Novod (Global)
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Jacob Martin Wiborg Rode (Global)
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Sina Meyer (Global)
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Christoffer Sho Togo Tullin (Global)
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Max Ung (Global)
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Alex Bruce (Global)
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References:
- Wharton S, Freitas P, Hjelmesæth J, et al. Once-weekly semaglutide 7.2 mg in adults with obesity (STEP UP): a randomised, controlled, phase 3b trial. Lancet Diabetes Endocrinol. 2025;13(11):949-963.
- Wegovy® (semaglutide) Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.
- Lingvay I, Bergenheim S, Buse J, 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(11):935-948.
- Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity. 2018;26(1):61–69.
- Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obes Rev. 2017;18(7):715–723.
- Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1–203.
- Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: March 2026. Available at: https://www.cdc.gov/obesity/adult-obesity-facts/index.html
- Centers for Disease Control and Prevention. Risk Factors for Obesity. Last accessed: March 2026. Available at: https://www.cdc.gov/obesity/risk-factors/risk-factors.html.
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