Novo Nordisk says obesity pill leads to 15% weight loss; availability “to be determined” By Reuters

© Reuters. FILE PHOTO: Flags are seen exterior Novo Nordisk headquarters in Copenhagen, Denmark, February 5, 2020. REUTERS/Jacob Gronholt-Pedersen/File Picture

By Deena Beasley

SAN DIEGO (Reuters) – Drugmaker Novo Nordisk (NYSE:) on Sunday stated a late-stage trial discovered {that a} high-dose oral model of its drug semaglutide helped chubby or overweight adults lose 15% of their physique weight, which is in step with current outcomes for different experimental weight problems capsules.

Novo plans to hunt U.S. Meals and Drug Administration approval of the high-dose tablet later this 12 months, however timing of a market launch is “to be decided,” in response to Mico Guevarra, medical director at Novo Nordisk.

The Danish firm has had provide points and struggled to maintain up with hovering U.S. demand for Wegovy and Ozempic, the respective model names for semaglutide offered as once-weekly injections for treating weight problems and diabetes.

The drug, designed to activate hormones that regulate blood sugar, gradual abdomen emptying and reduce urge for food, is a part of a brand new class that has reignited researcher and investor curiosity within the weight-loss remedy market, which is estimated to achieve $100 billion by the top of the last decade.

“We’re upping manufacturing as a lot as we are able to,” Guevarra stated in an interview right here on the sidelines of the annual assembly of the American Diabetes Affiliation.

Novo Nordisk already markets an oral semaglutide, beneath the model identify Rybelsus, for remedy of sort 2 diabetes, however its highest dose is 14mg.

The Section 3 trial of 667 overweight and chubby adults examined a dose of 50mg, displaying that it resulted in common weight lack of 15.1% after 68 weeks, when used alongside eating regimen and bodily exercise, in contrast with 2.4% for the placebo group.

Oral semaglutide, in response to the FDA label, must be taken within the morning on an empty abdomen, half-hour earlier than consuming, consuming, or utilizing every other oral remedy – you might be allowed solely 4 ounces of plain water. When you eat too quickly, the tablet is much less efficient, however in case you wait longer than half-hour its absorption could also be enhanced.

Different firms are engaged on weight problems capsules that do not have such dietary restrictions, and would in principle additionally attraction to sufferers who do not wish to inject themselves weekly.

On the ADA assembly on Friday, outcomes from an Eli Lilly (NYSE:) mid-stage trial confirmed that the best dose of its experimental tablet orforglipron helped individuals who have been overweight or chubby lose 14.7% of their physique weight after 36 weeks, and their weight reduction had not but appeared to plateau.

Novo Nordisk stated most sufferers in its weight problems trial reported gastrointestinal unintended effects from oral semaglutide, together with largely mild-to-moderate nausea, constipation, diarrhea and vomiting.

Outcomes from a separate Section 3 trial offered on the ADA assembly confirmed once-daily oral semglutide, at a dose of as much as 50mg, helped sufferers with sort 2 diabetes cut back their blood sugar ranges by as a lot as 2 proportion factors.

Particulars of each Novo trials have been additionally revealed within the peer-reviewed Lancet medical journal.