GLP-1 Agonists in Adolescents

STEP-TEEN trial design and results

STEP-TEEN (Weghuber et al., NEJM 2022) randomized 201 adolescents aged 12-17 with obesity in a 2:1 ratio to once-weekly semaglutide 2.4 mg or placebo, both with lifestyle intervention, for 68 weeks¹. Eligibility required BMI at or above the 95th percentile for age and sex plus one weight-related comorbidity, or BMI at or above the 99.7th percentile (Class III obesity).

At week 68, BMI declined by 16.1% in the semaglutide group versus increased by 0.6% in placebo (treatment difference -16.7 percentage points; 95% CI -20.3 to -13.2; P<0.001). The proportion achieving at least 5% body weight reduction was 73% versus 18%.

Adverse events in adolescents

Safety profile mirrored adult observations. GI events — nausea, vomiting, diarrhea, constipation — occurred in 62% of semaglutide vs 42% of placebo, mostly during dose-escalation and predominantly mild to moderate¹. Cholelithiasis occurred in 4 semaglutide-treated participants and 0 placebo. Discontinuation due to adverse events was uncommon (4.5% vs 0%). No unique pediatric safety signals were identified.

FDA approval and indication

On December 23, 2022, FDA approved Wegovy for chronic weight management in pediatric patients aged 12+ with initial BMI at or above the 95th percentile³. The approval positioned Wegovy alongside Saxenda (liraglutide 3.0 mg daily, approved for adolescents 2020). Tirzepatide (Zepbound) is approved only for adults 18+ as of 2026; the SURMOUNT-AT adolescent trial is in progress.

AAP 2023 clinical practice guideline

AAP released the first comprehensive pediatric obesity clinical practice guideline in January 2023². The guideline recommends pediatricians offer evidence-based weight-loss pharmacotherapy as adjunct to intensive health behavior and lifestyle treatment for adolescents 12+ with obesity, and consider referral for metabolic and bariatric surgery for adolescents 13+ with severe obesity. This represents a substantive shift from prior watchful-waiting recommendations.

Clinical considerations in adolescents

Dose escalation follows the adult schedule: 0.25 mg weekly for 4 weeks, then 0.5, 1.0, 1.7, and 2.4 mg weekly. Adolescents may be more susceptible to dose-escalation nausea and benefit from slower titration when tolerability is limiting.

Parental/guardian engagement is required for adherence. Reproductive counseling for adolescent girls is important given pregnancy contraindication; effective contraception should be discussed before initiation in sexually active adolescents.

Related editorial coverage

• STEP-1 — adult semaglutide trial
• Contraindications

Frequently asked questions

Can my 13-year-old take Wegovy?

Wegovy is approved for children 12+ with BMI at or above the 95th percentile. A 13-year-old meeting criteria is eligible. The decision is individualized based on comorbidities, prior interventions, and family engagement.

How much weight do teens lose on semaglutide?

STEP-TEEN: adolescents lost a mean 16.1% of BMI over 68 weeks on semaglutide 2.4 mg vs no weight loss on placebo. 73% achieved ≥5% body weight reduction.

Tirzepatide for adolescents?

Currently approved only for adults 18+. A pediatric trial (SURMOUNT-AT) is underway.

Side effects different in adolescents?

Similar profile, dominated by GI symptoms during dose escalation. Discontinuation rates are low. No unique pediatric signals.

Should medication replace lifestyle intervention in teens?

No. AAP guidelines and FDA labeling specify pharmacotherapy as adjunct to intensive lifestyle and behavioral intervention, not replacement.