Research and trials

Novo Nordisk reports 68-week weight loss data for semaglutide 2.4 mg

A 68-week trial reported maintained weight loss with semaglutide 2.4 mg, about ten weeks before the FDA approved Wegovy for weight management.

By the Semaglutides news desk·

Novo Nordisk reported on March 23, 2021 that adults with obesity treated with semaglutide 2.4 mg achieved and maintained a significant amount of weight loss in a 68-week trial [1]. The FDA approved a semaglutide product for weight management under the brand name Wegovy about ten weeks later, on June 4, 2021 [1].

The report described the result as "a significant amount of weight loss," but did not include an average percentage of body weight lost, the number of people in the trial or the trial's name. Those details have not been reported [1]. What the finding covered was both the loss itself and keeping it off for the length of the 68-week study period [1].

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. Novo Nordisk markets semaglutide medicines under the names Wegovy, Ozempic and Rybelsus [1]. The weight-management product that followed the March 2021 report is approved in two forms: a once-weekly injection given under the skin, and tablets taken once a day on an empty stomach. Injection pens deliver 0.25 mg, 0.5 mg, 1 mg, 1.7 mg or 2.4 mg, plus a higher-dose Wegovy HD pen of 7.2 mg; tablets come in 1.5 mg, 4 mg, 9 mg and 25 mg strengths [1].

The Wegovy label carries a boxed warning for an increased risk of thyroid C-cell tumors. Other warnings include acute pancreatitis, acute gallbladder disease, low blood sugar, acute kidney injury, allergic reactions, diabetic retinopathy complications in people with type 2 diabetes, increased heart rate, suicidal behavior and ideation, and pulmonary aspiration during general anesthesia or deep sedation. The most common side effects, reported in at least 5% of adults and children aged 12 and older, include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue and indigestion [1]. The label says Wegovy is not recommended for use with another semaglutide product or any other GLP-1 receptor agonist [1].

Why it matters for patients

The 68-week result sits behind a medicine that is now approved for long-term weight reduction in adults and in children aged 12 and older with obesity, and in adults with overweight who also have at least one weight-related condition, used together with a reduced-calorie diet and increased physical activity [1]. Because that indication is written for long-term use rather than a short course, a trial that measured both weight lost and weight kept off over 68 weeks speaks to how the drug is meant to be taken [1].

Cost and coverage are separate from the trial result. Since approval, Novo Nordisk has set a NovoCare Pharmacy price of $499 per month for all doses of Wegovy [1] and announced a reduction in US list prices for Wegovy, Ozempic and Rybelsus [1]. How much any individual pays depends on insurance and other factors that the trial report does not address [1].

What happens next

Milestones that followed the March 2021 report, according to the Wegovy approval record [1]:

  • June 4, 2021: FDA approves Wegovy (semaglutide) injection for adults with obesity.
  • December 23, 2022: FDA approves once-weekly Wegovy for obesity in teens aged 12 and older.
  • March 8, 2024: FDA approves Wegovy to reduce cardiovascular risk in adults with overweight or obesity and established cardiovascular disease.
  • August 15, 2025: Wegovy granted accelerated approval in the US for noncirrhotic MASH with moderate to advanced liver fibrosis.
  • December 22, 2025: FDA approves the Wegovy Pill, described as the first oral GLP-1 for weight loss in adults.
  • March 19, 2026: FDA approves Wegovy HD injection, a 7.2 mg dose.

Full results from the 68-week trial, including average weight loss and the number of participants, have not been reported [1].

Sources

  1. https://www.drugs.com/history/wegovy.html

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