FDA Approves Novo Nordisk’s New Wegovy HD Injection, Delivering the Highest Weight Loss to Date for a Wegovy Injection
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
| STEP UP Trial Results (at 72 weeks¹, ²) | ||||
|---|---|---|---|---|
| Wegovy® injection 7.2 mg | Wegovy® injection 2.4 mg | Placebo | ||
| Average weight reduction¹ | If all patients stayed on treatment (Efficacy estimand*) | ~21% (20.7%) | ~18% (17.5%) | ~2% (2.4%) |
| Analysis of all patients regardless of if they stayed on treatment² (Treatment regimen estimand**) | ~19% (18.8%) | ~16% (15.5%) | ~4% (3.9%) | |
| 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 trialSTEP 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 obesityObesity 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:
Wegovy (semaglutide) tablets are a prescription medicine used with a reduced-calorie diet and increased physical activity to:
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:
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:
Do not use Wegovy if:
Before using Wegovy, tell your healthcare provider if you have any other medical conditions, including if you:
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:
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 NordiskNovo 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.
References:
Source: Novo Nordisk
Source: HealthDay
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Wegovy (semaglutide) FDA Approval History
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Posted : 2026-03-20 08:49
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