China Trial UBT251 Delivers 19.7% Weight Loss; CagriSema Fails Phase 3
Novo Nordisk’s China phase 2 trial of UBT251 delivered up to 19.7% mean weight loss (–17.5 kg) versus 2.0% (–1.6 kg) for placebo over 24 weeks, with significant improvements in waist circumference, blood glucose, blood pressure and lipids and a mild-to-moderate gastrointestinal safety profile. Shares remain under pressure after CagriSema’s REDEFINE-4 phase 3 trial failed non-inferiority against tirzepatide, dragging ADRs to a 52-week low.
1. China Phase 2 Trial Results
The Chinese phase 2 trial of UBT251, conducted by United Biotechnology, evaluated once-weekly 2 mg, 4 mg and 6 mg doses in adults with overweight or obesity. From a baseline mean weight of 92.2 kg, the highest dose achieved a mean 19.7% (–17.5 kg) reduction versus 2.0% (–1.6 kg) for placebo over 24 weeks, with all active arms meeting statistical significance on secondary endpoints including waist circumference, blood glucose, blood pressure and lipid profiles.
2. Safety and Tolerability Profile
Across all dose groups, UBT251 demonstrated a consistent safety profile, with the most common adverse events being mild-to-moderate gastrointestinal symptoms that diminished over time in line with other incretin-based therapies. No new safety signals emerged and discontinuations were limited.
3. Global Development Pipeline
Novo Nordisk has launched a global phase 1b/2a trial enrolling about 330 participants for up to 28 weeks, with topline data expected in 2027, and plans a phase 2 study in type 2 diabetes in the second half of 2026. Under a licence agreement exceeding $2 billion in upfront and milestone payments, Novo Nordisk holds development rights outside mainland China, Hong Kong, Macau and Taiwan.
4. REDEFINE-4 Phase 3 Setback and Stock Impact
The REDEFINE-4 open-label phase 3 trial failed to demonstrate non-inferiority of CagriSema versus tirzepatide on weight loss at 84 weeks, prompting a 2.85% premarket drop to a 52-week low for the ADR. Investors are reassessing pipeline valuation as the company shifts focus back to its triple-agonist programme.