- FDA approved once-weekly semaglutide 7.2 mg for adults with obesity after tolerating 2.4 mg; product available April 2026.
- STEP UP (n=1,407) 72-week trial: ~21% mean weight loss (efficacy estimand) and ~19% (treatment-regimen estimand) with 7.2 mg.
- 31.2% on 7.2 mg achieved >=25% weight loss versus 15.3% with 2.4 mg and 0% with placebo.
- Common adverse events included nausea, vomiting and constipation; altered skin sensations (dysesthesia) occurred in 22% (7.2 mg) vs 6% (2.4 mg) vs 0.3% (placebo).
Approval
FDA approved Wegovy HD (semaglutide 7.2 mg) injection for adults with obesity who have tolerated 2.4 mg for at least 4 weeks; indicated as an adjunct to reduced‑calorie diet and increased physical activity when additional weight reduction is clinically indicated.
STEP UP trial
STEP UP was a 72‑week phase 3b randomized, double‑blind, placebo‑ and active‑controlled trial in 1,407 adults (BMI ≥30 kg/m2) without diabetes, comparing once‑weekly 7.2 mg vs 2.4 mg vs placebo alongside lifestyle intervention.
Efficacy
At 72 weeks the efficacy estimand showed ~21% mean weight loss with 7.2 mg (~19% per treatment‑regimen estimand); 31.2% of participants on 7.2 mg achieved ≥25% weight loss versus 15.3% for 2.4 mg and 0% for placebo.
Safety
Common adverse reactions included nausea, vomiting, dysesthesia, constipation, abdominal pain, fatigue, headache, dizziness, hair loss and flatulence; events related to altered skin sensation were reported in 22% (7.2 mg) vs 6% (2.4 mg) vs 0.3% (placebo).
Availability
Wegovy HD will be available in April through pharmacies, select telehealth providers, NovoCare Pharmacy, GoodRx and other channels; the approval supplements the existing Wegovy label.
