Novo Nordisk, a Danish pharmaceutical company, announced yesterday that a late-stage trial demonstrated the efficacy of a high-dose oral version of its drug semaglutide in assisting overweight or obese adults in losing 15% of their body weight.
Sports gear, weight loss – illustrative photo. Image credit: Alexandra Tran via Unsplash, free license
This outcome aligns with recent findings from other experimental obesity pills. Novo Nordisk intends to pursue regulatory approval for the high-dose pill in the United States and Europe later this year. However, the specific timeline has not been set yet.
The news was announced by Mico Guevarra, the medical director at Novo Nordisk.
The company already faces challenges in meeting the surging demand for its products. Its other products, Wegovy and Ozempic, are facing supply issues while trying to keep up with the rising demand in the United States.
Semaglutide works by activating hormones that regulate blood sugar, slowing down stomach emptying, and reducing appetite. It belongs to a new class of drugs that has revitalized interest among researchers and investors in the weight-loss treatment market, which is projected to reach a value of $100 billion by the end of the decade.
The chemical formula of Semaglutide. Image credit: Edgar181 via Wikimedia
Guevarra recently commented that the company is trying to increase the production rates of a new medication. “We are upping production as much as we can,” he said.
Novo Nordisk currently offers an oral semaglutide medication called Rybelsus for the treatment of type 2 diabetes, but its highest available dose is 14mg. In a recent late-stage trial involving 667 overweight and obese adults, a dose of 50mg of oral semaglutide was tested.
The trial showed that when combined with diet and physical activity, this higher dose resulted in an average weight loss of 15.1% after 68 weeks, in comparison to a 2.4% weight loss in the placebo group.
The FDA label for oral semaglutide indicates that it should be taken in the morning on an empty stomach, 30 minutes before eating, drinking, or taking any other oral medication. Only 4 ounces of plain water are allowed with the medication. Taking the pill too soon before eating may reduce its effectiveness, while waiting longer than 30 minutes may enhance its absorption.
Weight loss, nutrition – illustrative photo. Credit: TeroVesalainen via Pixabay, CC0 Public Domain
Other companies are also working on developing obesity pills that do not have the same dietary restrictions. These alternatives may appeal to patients who prefer not to undergo weekly injections.
Novo Nordisk reported that most participants in their obesity trial experienced gastrointestinal side effects from oral semaglutide, primarily mild-to-moderate nausea, constipation, diarrhea, and vomiting. Approximately 13% of patients experienced “altered skin sensation,” which largely resolved after several weeks, according to the company data.
Another late-stage trial presented at the ADA meeting revealed that once-daily oral semaglutide, at a dose of up to 50mg, assisted patients with type 2 diabetes in reducing their blood sugar levels by up to 2 percentage points.
Both trials conducted by Novo Nordisk were also published in the peer-reviewed medical journal, The Lancet.
Written by Alius Noreika