Novo Nordisk previews oral semaglutide 25 mg data ahead of ObesityWeek 2025

On October 20, 2025, Novo Nordisk said it would present new data on oral semaglutide 25 mg — the company's Wegovy pill — and results from its obesity pipeline at ObesityWeek 2025 ^[1]. The announcement came two days after the FDA approved oral semaglutide 7 mg and 14 mg (Rybelsus) to reduce cardiovascular risk in adults with type 2 diabetes at high risk, regardless of whether they had already had a cardiovascular event ^[1].

At the meeting, Novo Nordisk presented four new analyses of oral semaglutide 25 mg on November 5, 2025 ^[2]. The presentations came ahead of a regulatory decision: the FDA approved the once-daily semaglutide pill for weight loss on December 22, 2025 ^[1].

The approval rested on OASIS 4, a 64-week phase 3 trial in 307 adults with obesity or overweight and at least one weight-related health condition, none of whom had diabetes. Participants were assigned 2:1 to once-daily oral semaglutide 25 mg or placebo, alongside a reduced-calorie diet and increased physical activity ^[1]. Among those taking the pill, 76% lost at least 5% of their body weight, compared with 31% on placebo; starting weights averaged 235 pounds and 231 pounds, respectively ^[1]. When all patients stayed on treatment, average weight loss was about 17% (16.6%) with the pill versus about 3% (2.7%) with placebo. Counting everyone regardless of whether they stayed on treatment, the averages were about 14% (13.6%) versus about 2% (2.4%) ^[1]. A newly published study reported on September 17, 2025 had shown 16.6% weight loss with the same 25 mg dose ^[2].

The most common side effects in OASIS 4 were similar to those seen with semaglutide injection 2.4 mg and included nausea, diarrhea and vomiting ^[1]. The Wegovy label carries a boxed warning about thyroid C-cell tumors and lists other warnings, among them pancreatitis, gallbladder disease, low blood sugar, kidney injury, increased heart rate, suicidal thoughts and behavior, and pulmonary aspiration during anesthesia or deep sedation ^[2].

The tablets come in 1.5 mg, 4 mg, 9 mg and 25 mg strengths and are taken once daily on an empty stomach, while the Wegovy injection is given once weekly ^[2]. Novo Nordisk said the 1.5 mg starting dose would reach pharmacies and select telehealth providers in early January 2026, with savings offers at $149 per month ^[1].

Why it matters for patients

An oral GLP-1 changes the logistics of treatment more than the drug itself. Wegovy tablets are approved for adults with obesity, or adults with overweight plus at least one weight-related condition, and to reduce the risk of major cardiovascular events in adults with established cardiovascular disease and either obesity or overweight ^[1][2]. The injection carries an additional pediatric indication for patients 12 and older; the tablet does not ^[2]. The label advises against using Wegovy tablets with other semaglutide products or any other GLP-1 receptor agonist ^[2]. Cost and coverage have been a central issue for this drug class. The introductory savings price for the starting dose was $149 a month ^[1], and Novo Nordisk later announced list price cuts for Wegovy, Ozempic and Rybelsus on February 24, 2026 ^[2]. How insurers will cover the pill, and at what copay, has not been disclosed.

What happens next

Milestones from the company's own timeline: the four oral semaglutide 25 mg analyses at ObesityWeek on November 5, 2025 ^[2]; FDA approval of the Wegovy pill on December 22, 2025 ^[1]; the 1.5 mg starting dose in pharmacies in early January 2026 ^[1]. Later entries on the Wegovy timeline include the list price reduction on February 24, 2026 ^[2] and FDA approval of a higher-dose Wegovy HD injection on March 19, 2026 ^[2].