FDA approves Wegovy HD, a 7.2 mg semaglutide injection for weight loss

The FDA approved Wegovy HD, a 7.2 mg once-weekly semaglutide injection, on March 19, 2026, to reduce excess body weight and maintain weight loss long term in adults with obesity, or with overweight plus at least one weight-related condition ^[3][4]. It is the highest dose approved for the Wegovy injection, which previously topped out at 2.4 mg for weight loss ^[1]. Novo Nordisk said the new dose is for patients who have tolerated the 2.4 mg dose for at least four weeks and for whom additional weight reduction is clinically indicated ^[1].

The approval rests on the 72-week STEP UP trial, which enrolled 1,407 adults with obesity (BMI of 30 or higher) and without diabetes. Participants were randomly assigned in a 5:1:1 ratio to 7.2 mg, 2.4 mg, or placebo, alongside lifestyle intervention ^[1].

Average weight loss at 72 weeks was 20.7% with 7.2 mg, 17.5% with 2.4 mg, and 2.4% with placebo when the analysis assumed every patient stayed on treatment. Counting all patients regardless of whether they stayed on treatment, the figures were 18.8%, 15.5%, and 3.9% ^[1]. Novo Nordisk's corporate announcement lists 18.7% for the higher dose under that second analysis ^[4], and a summary published by AJMC also cites 18.7% ^[5]; the company's US release says 18.8% ^[1]. The gap is one-tenth of a percentage point.

About one in three patients taking 7.2 mg (31.2%) lost 25% or more of their body weight, compared with 15.3% taking 2.4 mg and none taking placebo ^[1]. In the 7.2 mg group, 89% lost at least 5% of body weight, versus 38% on placebo ^[1]. Mean starting weight was 248 pounds in the 7.2 mg and placebo groups and 257 pounds in the 2.4 mg group ^[1].

A separate 72-week trial, STEP UP T2D, enrolled about 512 adults with obesity and type 2 diabetes ^[5]. There, the 7.2 mg dose produced 14.1% mean weight loss under the efficacy analysis and 13.2% counting all patients ^[4][5], with 21.3% of patients losing at least 20% ^[4]. The FDA said that in people with both obesity and type 2 diabetes, the higher dose lowered A1C, a measure of average blood sugar, by a similar amount as the lower dose ^[3].

The most common side effects reported with the higher dose were nausea, vomiting, dysesthesia, constipation, abdominal pain, fatigue, headache, dizziness, hair loss and flatulence ^[1]. Events tied to altered skin sensation, such as sensitive skin, were reported by 22% of participants in the 7.2 mg arm, compared with 6% on 2.4 mg and 0.3% on placebo ^[1]. AJMC reports dysesthesia at 18.9% with 7.2 mg versus 4.9% with 2.4 mg and 0% with placebo in the type 2 diabetes trial ^[5]. The FDA said these reports generally resolved on their own or with a dose reduction, and that it is conducting further investigations into the reaction ^[3]. Wegovy carries a boxed warning about thyroid C-cell tumors seen in rodent studies; the drug is not for people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 ^[2][3].

The FDA granted the approval under its Commissioner's National Priority Voucher pilot program, making it the fourth product cleared under that pathway and the first GLP-1 medicine ^[3][4][5]. The agency said the decision came 54 days after filing ^[3].

Why it matters for patients

People who have tolerated 2.4 mg but want more weight loss now have a higher dose of the same drug available. Wegovy HD is a single-dose pen, like the lower injection strengths, and it is the sixth strength in that line ^[2]. Novo Nordisk says it is not a starting dose: patients must first take 2.4 mg for at least four weeks ^[1].

Wegovy 2.4 mg also carries an indication to reduce the risk of major cardiovascular events such as death, heart attack or stroke in adults with known heart disease plus obesity or overweight ^[1][2]. Whether the 7.2 mg dose produces the same heart benefit has not been reported; no cardiovascular outcomes trial for that dose is described in these materials.

The FDA's investigation into altered skin sensation is ongoing, so patients on the higher dose may hear more about that reaction later ^[3]. Pricing and insurance coverage for the new strength have not been disclosed; Novo Nordisk said coverage and savings information will be available when the product launches ^[1].

What happens next

Novo Nordisk expects to launch Wegovy HD in the US in April 2026, through more than 70,000 pharmacies including CVS and Costco, select telehealth providers, NovoCare Pharmacy and GoodRx ^[1]. The FDA will hold a public hearing in June to gather feedback on the voucher program that sped the review ^[3]. The 7.2 mg dose is already approved for adults with obesity in the EU and UK; Novo Nordisk expects decisions on a single-dose pen version there in the second half of 2026 ^[4].