Novo Nordisk to initiate Phase 3 study targeting overweight and obese patients in China

Novo Nordisk to initiate Phase 3 study targeting overweight and obese patients in China

Novo Nordisk to Initiate Phase 3 Study Targeting Overweight and Obese Patients in China

Following positive Phase 2 results for its triple agonist UBT251, Novo Nordisk and its Chinese partner United Biotechnology announced plans to initiate a Phase 3 trial for the drug in China, targeting patients with overweight or obesity. The Phase 2 trial, conducted in mainland China, demonstrated a statistically significant mean weight loss of 19.7% in participants treated with UBT251 after 24 weeks, compared to 2.0% in the placebo group. The drug, which targets GLP-1, GIP, and glucagon receptors, showed a safety profile consistent with incretin-based therapies, with gastrointestinal adverse events being the most common but generally mild to moderate.

The Phase 3 trial will build on these findings, aiming to further evaluate UBT251's efficacy and safety in a larger cohort of Chinese patients. United Biotechnology, which retains development rights for mainland China, Hong Kong, Macau, and Taiwan, will lead the trial. Novo Nordisk, holding global rights outside these regions, has also initiated a global Phase 1b/2a trial and plans a Phase 2 study in type 2 diabetes patients by mid-2026.

This development follows Novo Nordisk's recent expansion in China's obesity treatment market. A 2025 Phase 3 trial of semaglutide 2.4 mg in Chinese patients with overweight or obesity reported a mean weight loss of 11.8% versus 3.5% with placebo, with 85.4% of participants achieving ≥5% weight reduction. However, Novo's CagriSema, another obesity candidate, recently underperformed compared to Eli Lilly's Zepbound in a head-to-head trial, highlighting competitive pressures in the GLP-1RA space.

The Phase 3 trial of UBT251 represents a strategic step for Novo Nordisk to strengthen its pipeline in China, where obesity prevalence is rising and regulatory approvals for novel therapies are accelerating. Investors will likely monitor trial outcomes, pricing dynamics, and competition from Lilly and other entrants in the high-growth weight management market.

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