Saniona's Tesofensine Meets Primary and Secondary Endpoints in Phase 3 Obesity Registration Trial (Viking Study)

Outcomes summary

24-week, randomized, double-blinded, placebo-controlled Phase 3 registration trial in 372 obese patients; tesofensine achieved its primary endpoint with statistically and clinically significant weight loss for both doses (0.25 and 0.50 mg) compared to placebo; approximately 10% average weight loss was achieved at week 24, with more than half of patients losing more than 10% of their body weight; significant reductions were observed in obesity-related risk factors.

Limitations

Trial conducted in Mexico with Medic regulatory filings planned for that territory; results may not generalize to all populations; longer-term safety and maintenance of weight loss beyond 24 weeks remain to be established; cardiovascular monitoring showed low but statistically significant increase in heart rate.

Notes

Primary source: Saniona AB / Productos Medix Phase 3 Viking Study (2018).