Results

Novo Nordisk’s new obesity data tip the scales in semaglutide’s favor as landmark pivotal program looms

Novo Nordisk has rolled out new data points to back its belief that their newly approved GLP-1 diabetes drug semaglutide also has the inside track on a blockbuster designation for obesity.

Novo’s researchers took center stage at the Endocrine Society’s annual conference in Chicago with a new round of Phase II numbers showing that the drug spurred weight loss of up to 13.8% among a group of obese adults.

Altogether 83% of people treated with semaglutide 0.4 mg lost greater than or equal to 5% of their body weight — compared to 23% with placebo and 66% with liraglutide (Saxenda) 3 mg, which also factored in the study. Right at 2 of every 3 patients lost at least 10% of their body weight, compared to 10% in the placebo arm and half that in the liraglutide group.

Mads Krogsgaard Thomsen

Novo Nordisk already has solid efficacy data on weight loss among the diabetics it treated during its development program for the drug, which helped inspire the company to make a big investment in obesity.

Those collective numbers help set the stage for a big Phase III pivotal program, which includes 4,500 obese patients and a massive cardio outcomes study involving 12,500 people.

Novo has set out to win in a field where there’s been nothing but disappointment and failure for more than a decade. Just a few days ago Orexigen was forced to file for bankruptcy after racking up inadequate sales of Contrave. And that drug had already beaten out Qsymia and Belviq, two other therapies from the same class of biotechs that competed for the FDA’s attention 5 years ago. Contrave also outperformed Novo’s Saxenda, which has a more modest impact on weight.

Novo has plans to go beyond semaglutide, working on combination therapies that may be able to trim as much as 25% of body weight, which would rival the performance of some popular weight-loss procedures.

Some analysts estimate the drug could be worth more than $2 billion a year in sales 5 years from now. And Novo will likely tout the weight loss that diabetics can expect as they launch a major marketing campaign triggered by the FDA’s approval of the drug last December as Ozempic. In this field manufacturers look for every advantage they can get to beat the competition, which in this case is primarily Eli Lilly and Sanofi.

“In line with our long-term commitment, we plan to start the STEP phase 3 clinical development programme later this year to explore the potential of once-weekly semaglutide as a treatment for people with obesity,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.


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