Novo Nordisk A S — Wegovy EMA EPAR variation assessment report (EMEA/H/C/005422, 2022)
Novo Nordisk A S · 2022 · EMA EPAR variation assessment report · company profile →
Report summary
This report assesses a Type II variation for Wegovy (semaglutide) by Novo Nordisk A/S, proposing a higher 7.2 mg maintenance dose for weight management. Based on the STEP UP and STEP UP T2D studies, the 7.2 mg dose demonstrated greater weight loss than placebo and the 2.4 mg dose, with significant reductions in body weight, fat, and improved cardiometabolic markers. However, the additional efficacy benefit over the 2.4 mg dose was generally small and of uncertain clinical relevance for most patients, despite Novo Nordisk arguing for its utility in achieving higher weight loss targets. The 7.2 mg dose was associated with increased adverse events, particularly gastrointestinal issues, dysaesthesia, and alopecia, leading to higher discontinuation rates. While some patients may benefit from the higher dose, the increased safety risks and marginal additional efficacy raise concerns about its overall clinical utility compared to the 2.4 mg dose.
Key findings — cited to the page
| Body weight change from baseline (%) | -18.71 % | STEP UP · p.5 |
| Body weight change from baseline (%) | -3.90 % | STEP UP · p.5 |
| Proportion of participants achieving body weight reduction ≥5% | 73.93 % | STEP UP T2D · p.5 |
| Randomisation ratio | 3:1:1 | STEP UP T2D · p.4 |
| Body weight change from baseline (%) | -15.61 % | STEP UP · p.5 |
| BMI change from baseline | -1.64 | STEP UP · p.48 |
| Procedure No. | EMA/VR/0000284664 | Wegovy · p.1 |
| Randomisation ratio | 5:1:1 | STEP UP · p.4 |
| Study type | Phase 3b | NN9536-4999, NN9536-7545 · p.4 |
| Study type | Phase 3a | NN9932-4737 (OASIS 1) · p.4 |
| Approved dose for weight management | 2.4 mg | Wegovy · Global · p.4 |
| Estimated treatment difference (ETD) in body weight change vs placebo | -14.81 % points | STEP UP · p.5 |
Source: Novo Nordisk A S ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →