Ozempic in Pill Form provides spectacular weight loss results in a major test

A large clinical trial revealed that a daily semaglutide pill produced weight loss and healthy health benefits comparable to injectable versions, preparing the way for a possible approval of the FDA later this year.

A daily pill containing semaglutide, the active ingredient of the Ozempic, helped overweight adults or the obesity to lose much more weight than placebo over 64 weeks, according to results published today in the New England Journal of Medicine. The phase 3 study, Oasis-4, positions an oral version of Ozempic as a potential option without a needle for chronic weight management, pending the American regulatory review.

Made on 22 sites in four countries, Oasis-4 has randomly assigned 307 diabetes adults in a 2: 1 report to receive oral semaglutide 25 mg (n = 205) or a placebo (n = 102), parallel to the life council. The trial included a 12 -week dose climbing and seven weeks of treatment, covering 71 weeks in total with 64 weeks of treatment. Participants had a body mass index of at least 30, at least 27 with at least one complication linked to weight.

Investigators report two additional estimates of the effect. As part of “the test, the estimate of the product”, which reflects the results if all the participants adhered to the treatment as expected, the people taking the semaglutide pill lost an average of 16.6% of their basic body weight in the week 64, against 2.7% on the placebo. More than a third (34.4%) in the oral semaglutide group reached at least 20% weight loss, compared to 2.9% with a placebo. Using “the more pragmatic treatment policy, which has the results, regardless of perfect membership, average weight loss was 13.6% with the pill against 2.2% with a placebo and 29.7% against 3.3% reached at least 20% of weight loss.

In analyzes, participants on the pill were significantly more likely to hit weight loss thresholds of 5%, 10%, 15% and 20% than those of placebo (all p <0.001). The physical function, measured by the IWQOL-Lite-CT instrument, has also improved significantly with the pill, just like several cardiovascular risk factors.

Industry prospect

“The 25 mg oral semaglutide data show convincing efficiency for an oral weight management medication with a weight loss of 16.6% and a safety and tolerability profile in accordance with Wegovy injection,” said Martin Holst Lange, scientific director and executive vice-president of research and development at Novo Nordisk. “Currently, less than 2% of persons with obesity in the United States receive obesity drugs and Wegovy in a pill can also respond to the preference of patients for oral treatment. Approval awaiting the FDA, sufficient supply will be available to meet the expected American demand as we hope to define a new treatment reference for oral weight loss drugs for overweight or obesity. ”

Although Ozempic is the brand used for semaglutide in type 2 and Wegovy diabetes is the chronic weight management brand, the company and external experts have frequently compared efficiency in the various semaglutide formulations. In Oasis-4, Novo Nordisk notes that the oral results were comparable in amplitude to those reported previously for the injectable formulation.

Gastrointestinal side effects – well known for the GLP -1 class – were the most frequent unwanted events and were generally light to moderate and transient. Nausea occurred in 46.6% of people on the pill against 18.6% on the placebo; Vomiting occurred in 30.9% respectively against 5.9%. Adverse events leading to stop took place in 6.9% on the pill and 5.9% on the placebo. Serious adverse events were reported respectively in 3.9% and 8.8%. The investigators said that the overall tolerability profile is aligned with that observed for the injectable semaglutide through a vast post-commercialization experience.

Clinical implications

“The results of the Oasis 4 trial also highlight the significant impact that the semaglutide may have for sustainable weight loss and wider health services,” said Sean Wharton, MD, the main study and medical director of the Wharton Medical Clinic. “The 25 mg oral semaglutide is based on proven efficiency and the safety and tolerance profile established by the semaglutide and represents significant progress in the treatment of obesity. Overweight people or obesity have individual preferences, and with oral semaglutide as a new potential treatment option, more of those who are not under treatment today can consider the GLP-1 treatment. ”

Novo Nordisk submitted a new request for medication to the US Food and Drug Administration in February 2025 for the oral semaglutide once a day as therapy for chronic weight management-the first oral GLP-1 to file for this indication in the United States. The company claims that the FDA exam should conclude by the end of this year. If it is approved, the production of the pill for weight management will be fully based in the United States, the manufacturing already underway.

Experts warn that the Oasis-4 has excluded people with diabetes, so that the results may not become widespread in all patients who could use semaglutide. The duration on study treatment was 64 weeks; Longer monitoring will help clarify the maintenance of weight loss and long -term cardiometabolic results after stabilization or dose stop.

Reference: “Oral semaglutide at a dose of 25 mg in overweight or obesity adults” by Sean Wharton, Ildiko Lingvay, Pawel Bogdanski, Ruben Duque Do Vale, Stephan Jacob, Tobias Karlsson, Chaithra Shaji, Domenica Rubino and W. Timothy Garvey, September 17, 2025 New England Journal of Medicine.
Doi: 10.1056 / Nejmoa2500969

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