Dive Brief:
- Novo Nordisk is planning a new Phase 3 trial of its next-generation obesity drug CagriSema that will test different doses and longer duration of treatment, the company said Wednesday.
- The announcement comes six weeks after the Denmark-based company released data from another Phase 3 trial that underperformed executives’ expectations on weight loss. Other studies are ongoing, including one with results due this quarter, and Novo plans in early 2026 to ask for regulatory approval of CagriSema.
- Novo, which pioneered the use of GLP-1 medicines like Wegovy for weight loss, is in a tight competition with Eli Lilly. The rivalry sharpened when Lilly’s drug Zepbound showed it helped people lose more weight than Wegovy in a head-to-head trial, a finding that put greater scrutiny on Novo’s pipeline.
Dive Insight:
Novo had suggested they would conduct further trials when the Phase 3 study Redefine-1 read out in December. On Wednesday, alongside earnings for the fourth quarter, executives gave further detail on their research plans based on data analyses they’ve conducted since then.
Trial volunteers receiving the highest dose of CagriSema at the end of Redefine-1 lost less body weight, about 22%, than people who got lower doses. In the new trial, dubbed Redefine-11, the high dose will tested for longer than the 68 weeks Redefine-1 ran.
Some participants on lower doses in Redefine-1, meanwhile, had reduced them because of gastrointestinal side effects. Novo wants to test whether re-escalating their doses in Redefine-11 can drive further benefit than the 25% body weight loss this group experienced.
Cantor Fitzgerald analyst Prakhar Agrawal described Novo’s additional results as “head-scratcher data” because the weight loss and side effect profile don’t match up to what is typically seen as dose levels increase. That could have been because of how fast Novo researchers escalated dosing in the Phase 3 trial, Agrawal wrote in a note to clients.
“A lot of fine-tuning still needs to be done on dosing,” he wrote, adding that people in the low-dose group hit a plateau at around 52 weeks while those in the higher-dose group didn’t appear to have at the trial’s end at week 68.
Novo reported total sales of 290 billion kroner, or about $42 billion, for 2024, a 26% increase over 2023. Sales of Wegovy reached 58 billion kroner, or $8.4 billion, an 86% increase.
Editor's note: This story was updated to reflect follow-up analysis from Cantor Fitzgerald analyst Prakhar Agrawal.
