Novo claims edge over Lilly's newly approved GLP-1 pill in cross study

Novo Nordisk said today that its oral Wegovy outperformed Eli Lilly's recently approved GLP-1 pill in a cross-trial comparison drawing on previously published phase 3 data. The announcement comes just one day after the FDA approved Lilly's closely watched GLP-1 pill, orforglipron, now branded as Foundayo.

The treatment comparison, called the Orion study, showed that 25 mg of Novo's oral Wegovy delivered 3.2% more weight loss than 36 mg of Lilly's Foundayo, the Danish drugmaker said in its press release.

Using data from the Wegovy Oasis 4 and Foundayo Attain-1 trials, the Orion study also found that people taking Lilly's pill were significantly more likely to stop taking the medication due to side effects, with about 4 times higher odds of quitting for any reason and 14 times higher odds of quitting due to gastrointestinal issues. This is important, as discontinuation can adversely affect results and outcomes.

Although the study was population-adjusted, Novo said it is not a head-to-head randomized controlled trial (RCT) and does not include new clinical data. While RCTs remain the gold standard for evaluating new treatments, clinicians often rely on cross-trial comparisons to assess competing treatments when head-to-head randomized data isn't available, though this approach comes with limitations.

Novo says it will provide additional details of the Orion study at the Obesity Medicine Association's annual conference next week in San Diego.

According to a separate online study, also cited in Novo's press release, roughly four out of five adults (84%) with overweight or obesity said they prefer Novo's drug profile over Lilly's. The study, dubbed Optic, surveyed 800 people in the U.S. last fall, the pharma titan said.

"These studies add to the growing body of evidence supporting the clinical strength of semaglutide and highlight attributes that patients value when choosing an obesity medicine that fits their lifestyle," executive vice president of Novo Nordisk's U.S. operations, Jamey Millar, said.

However, the findings come with notable limitations, including the study's observational design, potential selection bias and use of hypothetical profiles. Because the study was conducted before Foundayo was approved, the profiles may differ from the final FDA-approved labels, Novo said.

The data drop comes as both industry giants work to differentiate their products and vie for dominance in the oral GLP-1 market, which J.P. Morgan expects to be worth $200 billion by the end of the decade. While Foundayo carries no food, water or timing restrictions, oral Wegovy requires patients to take it each morning on an empty stomach with a small sip of water and wait 30 minutes before eating.

These differences in administration burden and tolerability could be a factor for patients and prescribers when choosing between therapies, ultimately determining who leads the market.

Since hitting pharmacy shelves in early January, the Wegovy pill has been prescribed to more than 600,000 patients. Its rollout is being hailed as one of the most successful new drug launches, with early uptake outpacing that of injectable options. Truveta data suggests that more than a third (36.1%) of those taking Novo's pill are new to the drug class.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.