STEP TEENS underpins the adolescent Wegovy approval

On December 23, 2022, the FDA approved once-weekly Wegovy injection for the treatment of obesity in teenagers aged 12 years and older ^[1]. This was the first time a GLP-1 receptor agonist was cleared for weight management in this age group ^[1]. The approval expanded on Wegovy's original 2021 clearance for adults with obesity ^[1].

The pediatric approval rested on the STEP TEENS trial, according to the source material, though the sources here do not provide the specific weight-loss percentages, dosing schedule, or side-effect data reported in that adolescent study. What is documented is the broader label change: Wegovy injection is now indicated, along with a reduced calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity ^[1].

Wegovy is supplied as a prefilled, single-dose pen delivering doses of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg, or the newer Wegovy HD at 7.2 mg, taken once weekly by injection into the abdomen, thigh, or upper arm ^[1]. The drug's label carries a boxed warning about an increased risk of thyroid C-cell tumors, along with warnings for acute pancreatitis, acute gallbladder disease, hypoglycemia, acute kidney injury, hypersensitivity reactions, increased heart rate, suicidal behavior and ideation, and pulmonary aspiration risk during general anesthesia or deep sedation ^[1]. Common side effects reported in adults or adolescents aged 12 and older, occurring in 5% or more of patients, include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, and several other gastrointestinal symptoms ^[1].

Why it matters for patients

Before this approval, families of teenagers with obesity had no GLP-1 option backed by FDA clearance specifically for that age group ^[1]. The 2022 decision meant that pediatric patients 12 and older could be prescribed the same weekly injection already used in adults, under the same general goal of reducing excess body weight when combined with diet and exercise changes ^[1]. This shifted obesity treatment options for adolescents, a population where treatment choices had been limited.

The approval also came with the same boxed warning and precautions that apply to adult use, meaning families and prescribers weighing this option for a teenager would need to consider the same thyroid tumor warning, gastrointestinal side effects, and other risks listed on the adult label ^[1]. The sources do not specify whether adolescents experienced side effects at different rates than adults, so that comparison is not yet available from this material.

What happens next

Wegovy's label has continued to expand since the 2022 adolescent approval. In March 2024, the FDA approved Wegovy for cardiovascular risk reduction in adults with overweight or obesity and established cardiovascular disease ^[1]. In August 2025, Wegovy received accelerated approval for treating metabolic dysfunction-associated steatohepatitis, or MASH, with moderate to advanced liver fibrosis in adults ^[1]. That MASH indication remains contingent on confirmatory trial results verifying clinical benefit ^[1]. In December 2025, the FDA approved an oral Wegovy pill, described as the first and only oral GLP-1 for weight loss in adults ^[1]. In March 2026, the agency approved the higher-dose Wegovy HD injection, said to deliver the highest weight loss to date for a Wegovy injection ^[1]. None of these later approvals altered the original 2022 adolescent obesity indication, which remains specific to ages 12 and older ^[1].