The European Medicines Agency based its positive opinion on clinical trials involving more than 4,740 participants. Data from these studies demonstrated that patients taking the drug saw weight reductions ranging from 5% to 11% over 72 weeks, significantly outperforming the 2% to 2.5% loss observed in the placebo groups. The treatment is intended for use in conjunction with a controlled diet and physical exercise.

While the recommendation represents a significant hurdle cleared, the final decision rests with the European Commission, which maintains the authority to grant official marketing authorization. Clinical observations noted common side effects including nausea, vomiting, and diarrhea. Investigators reported these gastrointestinal issues appeared most frequently during dose escalation phases, with symptoms subsiding as patients acclimated to the medication.