Novo Nordisk Announces Positive Phase IIIb PIONEER PLUS Trial Results for New Higher-Dose Oral Semaglutide (Rybelsus 25mg and 50mg) in Adults with Type 2 Diabetes

On March 24, Novo Nordisk announced the key positive results of the Phase IIIb PIONEER PLUS study of oral semaglutide Rybelsus (25mg and 50mg) for the treatment of adult patients with type 2 diabetes.

The 68-week study aims to evaluate the efficacy and safety of Rybelsus (50mg or 25mg, once daily) compared with Rybelsus (14mg, once daily) in treating adult patients with type 2 diabetes who were previously treated with other oral hypoglycemic agents. The primary endpoints are the changes in glycated hemoglobin (HbA1c) levels at weeks 52 and 68.

The results showed that, from the perspective of the investigational drug (all subjects adhered to Rybelsus treatment and did not require other type 2 diabetes medications):

At Week 52, the HbA1c reduction effect was more significant with Rybelsus 25mg and 50mg doses compared to the 14mg dose. Additionally, patients in the Rybelsus (25mg) and Rybelsus (50mg) groups experienced weight reductions of 7.0kg and 9.2kg, respectively, from a baseline of 96.4kg, showing significantly better weight loss results than the Rybelsus (14mg) group (4.5kg).

From the perspective of treatment strategy (subjects adhering to Rybelsus treatment or starting other type 2 diabetes medications):

At Week 52, the HbA1c reduction was significantly greater with Rybelsus 25mg and 50mg compared to Rybelsus 14mg. Additionally, patients in the Rybelsus 25mg and 50mg groups experienced weight reductions of 6.7kg and 8.0kg, respectively, from a baseline weight of 96.4kg, demonstrating significantly better weight loss effects than the Rybelsus 14mg group (4.4kg).

PIONEER PLUS Study Results (Source: Novo Nordisk Official Website)

In terms of safety, all doses of oral semaglutide were well tolerated with good safety profiles. The most common adverse events were gastrointestinal reactions, the vast majority of which were mild to moderate and decreased over time. Gastrointestinal reactions were most common during the dose-escalation period, with a higher incidence in the Rybelsus (25mg and 50mg) groups compared to the Rybelsus (14mg) group.

Based on the above positive results,Novo Nordisk is expected to submit a new specification listing application for Rybelsus in the United States and the European Union in 2023.Currently, Rybelsus (7mg or 14mg) has been approved for marketing in the United States and Japan, and it is expected to be approved in China in the first half of this year.

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