Oral Semaglutide 50mg Tablet Achieves 17.4% Weight Loss in 68-Week Phase III Obesity Trial, NDA Filing Planned for This Year

On May 22, Novo Nordisk announced the weight loss Phase IIIa OASIS 1 study data for the 50mg tablet of semaglutide.

The OASIS 1 study enrolled 667 obese or overweight adult patients with one or more comorbidities to evaluate the weight-loss efficacy and safety of oral semaglutide (50 mg, once daily) compared to placebo. Patients in both the treatment and control groups received lifestyle intervention during the trial. The primary endpoints of the study were the percentage change in body weight and the proportion of patients achieving ≥5% weight loss at week 68.

From the perspective of the trial drug (all patients adhered to treatment with 50mg semaglutide tablets): the average baseline weight of the patients was 105.4kg. Patients in the 50mg semaglutide group experienced weight loss.17.4%, while patients in the placebo group experienced a 1.8% reduction in body weight, which was statistically significant. In addition,89.2%Patients treated with semaglutide 50mg achieved ≥5% weight loss after 68 weeks, compared to 24.5% in the placebo group.

From the perspective of treatment strategy (regardless of whether patients adhere to semaglutide 50mg tablet treatment): weight loss in patients taking semaglutide 50mg15.1%, while the weight of patients in the placebo group decreased by 2.4%, which was statistically significant. Additionally,84.9%Patients treated with semaglutide 50mg achieved weight loss of ≥5% after 68 weeks, compared to 25.8% in the placebo group.

In addition, the 50mg tablet of semaglutide has good safety and tolerability. The most common adverse events are gastrointestinal reactions, and the vast majority are mild to moderate, decreasing over time, consistent with GLP-1 receptor agonist drugs. Gastrointestinal adverse events are most prominent during the dose escalation period.

Martin Holst Lange, Executive Vice President of Development at Novo Nordisk, said: "We are very pleased with the weight loss effects shown by the once-daily oral formulation of semaglutide in obesity. The results indicate that the 50mg tablet is comparable in weight loss to the semaglutide injection (2.4mg) in the STEP 1 study for treating obesity. Having the option to take semaglutide tablets daily or to inject semaglutide weekly could provide patients and healthcare providers with the opportunity to choose the treatment that best suits individual preferences."

Novo Nordisk has conducted four OASIS studies, the remaining three of which are:

OASIS 2 Study (N=198): A 68-week trial evaluating the weight-loss efficacy and safety of semaglutide 50mg tablets in East Asian (including Japan) obese or overweight populations with one or more comorbidities.

OASIS 3 Study (N=200): A 44-week trial evaluating the weight-loss efficacy and safety of semaglutide 50mg tablets in Chinese populations with obesity or overweight, accompanied by one or more comorbidities.

OASIS 4 Study (N=300): A 64-week trial evaluating the weight-loss efficacy and safety of semaglutide 25mg tablets in obese or overweight individuals with one or more comorbidities.

Novo Nordisk is expected to seek regulatory approval in the U.S. and EU for a 50mg tablet version of semaglutide in 2023. However, the global launch timing of the 50mg semaglutide tablet will depend on the prioritization within Novo Nordisk’s product portfolio and its production capacity.

In the past, since the launch of Eli Lilly's blockbuster weight-loss drug tirzepatide, Novo Nordisk has been under pressure. After all, compared to tirzepatide, the weight-loss advantage of Wegovy seems to have diminished. The 2.4mg semaglutide injection resulted in a 15.8% weight reduction over 68 weeks (STEP 8 study), while the 15mg tirzepatide injection achieved a 20.9% weight reduction over 72 weeks (SURMOUNT-1 study). Moreover, Eli Lilly has taken direct action by initiating a head-to-head Phase III study comparing tirzepatide with semaglutide for weight loss. Under the pressure following the success of a head-to-head Phase III study on glycemic control between tirzepatide and semaglutide, Novo Nordisk needs to achieve a new breakthrough with its oral semaglutide tablets to break this deadlock. With the recent disclosure of OASIS 1 study data showing that the weight-loss effect of 50mg semaglutide tablets is close to that of the 15mg tirzepatide injection (non-head-to-head), Novo Nordisk can breathe a sigh of relief.

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