Contemporary off of presenting eye-popping knowledge for its weight problems drug candidate semaglutide, Novo Nordisk is upping the ante with a extra user-friendly model of the remedy.
The section 3a program will enroll about 1,000 obese contributors and can look at the efficacy and security of the oral remedy versus placebo. The research will kick off within the second half of this yr.
Marketed as Ozempic, semaglutide is already in widespread use as a remedy for Sort 2 diabetes. However the Danish firm hopes to faucet a a lot bigger market as a remedy for weight problems. Oral semaglutide is permitted in Sort 2 diabetes as Rybelsus.
“There may be vital unmet medical want with weight problems remedy at the moment,” Novo’s government VP of growth Martin Holst Lange mentioned in a assertion. “With oral semaglutide we intention to introduce a handy and efficient remedy choice.”
In the meantime, the injected model of semaglutide is already beneath regulatory evaluation for weight problems in america and Europe. Novo Nordisk expects a ruling from the FDA in the course of this yr, with Europe to observe in 2022.
The drug, an analog of the human glucagon-like peptide-1 hormone, induces weight reduction by decreasing starvation and growing the sensation of fullness.
In February, Novo Nordisk launched spectacular outcomes of a section 3 trial of 1,961 adults who acquired a weekly 2.4 mg dose by self-injection. A 3rd of sufferers misplaced greater than 20% of their physique weight over a 68-week interval, with the typical participant dropping 33 kilos, investigators discovered. As well as, many noticed enhancements of their threat elements for diabetes and coronary heart illness.
The outcomes had been a “game-changer,” research co-author Rachel Batterham of College Faculty at London mentioned on the time. Different consultants had been extra reserved, noting that the drug causes gastrointestinal points and that every one research of weight problems medicine must be thought of over an extended time frame to find out true efficacy.
Shortly after Novo’s semaglutide posted these spectacular knowledge, Eli Lilly’s dual-action candidate tirzepatide out-performed the Novo medication in decreasing blood sugar ranges and physique weight in diabetes sufferers. In all, the info set the scene for a probably fascinating competitors between Novo Nordisk and Lilly as they vie for diabetes sufferers and as Novo eyes separate weight problems indications for its medicines.
Novo additionally markets a weight-loss shot Saxenda, a model of its older GLP-1 diabetes drug Victoza. That weight problems medication generated about $900 million in gross sales final yr.