Novo Nordisk’s oral semaglutide on par with injectable version in weight loss and safety

June 25, 2023 10:39 PM EDTUpdated 05:32 AM R&D
Novo Nordisk’s oral semaglutide on par with injectable version in weight loss and safety
Katherine Lewin
News Reporter
An oral version of Novo Nordisk’s semaglutide helped patients taking the highest dose lose 15% of their body weight, the company reported in a new update.

It’s on par with Novo’s Wegovy, which is the injectable version of semaglutide that is approved for weight loss. Obese or overweight patients who took Wegovy lost 15% of their weight from a baseline of 105 kg, according to the FDA label.

In the 68-week Phase III OASIS-1 study, Novo tested out escalating doses up to 50 mg of semaglutide in over 600 patients who are overweight or obese, according to data released at the American Diabetes Association’s annual conference on Sunday night. The study found that participants taking the 50 mg dose saw a 15.1% body weight reduction compared to 2.4% on placebo.

Of the patients taking the 50 mg dose, 51% reported nausea, while 26% had constipation and diarrhea — and 5.7% of patients taking the highest dose discontinued treatment compared to 3.6% on placebo. Wegovy had a discontinuation rate of 13%.

These are the latest data for Novo’s powerhouse semaglutide franchise, which includes Wegovy; Ozempic, an injection approved for type 2 diabetes; and Rybelsus, an oral version of semaglutide first approved in 2019 for type 2 diabetes. Eli Lilly’s Mounjaro, approved for type 2 diabetes, is also an injection.

It’s up to patients to decide whether they want to take an oral or injectable version of semaglutide since the drug’ overall efficacy and safety are both similar with “no really big differences there,” Filip Knop, a professor of endocrinology at the University of Copenhagen and co-author of the study, told journalists on Sunday.

But there are some restrictions as to how patients take oral semaglutide: They need to take the pill before eating or drinking with half a glass of water and then wait 30 minutes before drinking coffee or having breakfast so they can absorb as much as possible of the active compound. With injectables, the patient has to learn how to use the needle.

Knop estimates that in his clinical practice about 25% of patients with type 2 diabetes prefer taking an oral semaglutide pill once a day. The rest would rather do a weekly injection of semaglutide.

Diabetes trial
Novo Nordisk also shared data on Sunday from a Phase IIIb study that compared 25 mg and 50 mg doses of Rybelsus, its oral semaglutide, against the 14 mg version that’s currently the maximum approved dose.

The PIONEER PLUS study, which tested the drug in people with type 2 diabetes, found that through 52 weeks the highest doses led to larger reductions in HbA1c, a measurement of blood sugar levels. Patients taking the 14 mg dose saw a 1.5% reduction in HbA1c, while those on the 25 mg dose saw a 1.8% reduction and those on 50 mg saw a 2.0% reduction.

In the secondary endpoint, investigators looked at change in body weight, though that wasn’t the main goal of the study.

Patients taking the 25 mg dose lost an average of 6.7 kilograms (14.7 pounds); patients taking 50 mg saw an average loss of 8 kilograms (17.6 pounds); and patients taking 14 mg lose 4.4 kilograms (9.7 pounds) on 14 mg from a baseline body weight of 96.4 kilograms. In addition, Novo found that 67% of patients on the 50 mg dose had a body weight loss of 5% or more compared to 41% of patients taking 14 mg, and 37% taking 50 mg saw a 10% or greater loss of body weight compared to 14% on the 14 mg.

The most common side effects were nausea, vomiting and diarrhea – 13% of patients taking 50 mg had to discontinue treatment compared to 10% on 14 mg.