Novo Nordisk is set to launch a new Phase 3 trial for its advanced obesity treatment, CagriSema, with plans to evaluate a range of doses and extended treatment periods, the company revealed on Wednesday.
The announcement follows the release of mixed results from a previous Phase 3 trial, which fell short of the company’s weight-loss expectations. While the trial, known as Redefine-1, was conducted in December, additional studies are still underway, with some results expected later this quarter. Novo aims to seek regulatory approval for CagriSema by early 2026.
As a leader in GLP-1 weight loss medications such as Wegovy, Novo Nordisk finds itself in increasingly fierce competition with Eli Lilly. The rivalry intensified following a study showing that Lilly’s Zepbound surpassed Wegovy in weight-loss effectiveness in a direct comparison trial, prompting increased scrutiny of Novo’s drug pipeline.
Details of the New Trial
Novo Nordisk had hinted at the possibility of additional trials after the Redefine-1 trial’s underwhelming results. On Wednesday, alongside their Q4 earnings report, the company outlined their research plans based on comprehensive data analysis conducted since December.
In Redefine-1, participants receiving the highest dose of CagriSema exhibited only a 22% reduction in body weight by the trial’s end, which was lower than those on moderate doses. The new study, named Redefine-11, will extend the treatment duration beyond the 68 weeks of Redefine-1 to test whether a longer treatment period can yield more significant weight loss results.
Moreover, some participants on lower doses in Redefine-1 reduced their doses due to gastrointestinal side effects. Novo intends to explore whether re-escalating their doses in Redefine-11 could lead to weight loss greater than the 25% seen in the low-dose group.
Prakhar Agrawal, an analyst at Cantor Fitzgerald, raised concerns about the Redefine-1 results, calling the data “head-scratcher data” due to the unexpected correlation between dosage levels and weight loss. Agrawal speculated that the issue could be related to how quickly dosing was escalated during the Phase 3 trial. He pointed out that participants in the low-dose group plateaued around week 52, while those on higher doses did not seem to experience a plateau by the 68-week mark.
Financial Performance
In addition to the update on CagriSema, Novo Nordisk reported robust financial performance for 2024, with total sales reaching 290 billion Danish kroner (approximately $42 billion), marking a 26% increase from the previous year. Notably, sales of Wegovy saw a remarkable 86% increase, reaching 58 billion kroner (around $8.4 billion), underscoring the success of the company’s weight-loss drug portfolio.
With new trials underway, Novo Nordisk remains committed to advancing its obesity treatment pipeline, while navigating the competitive landscape shaped by rival pharmaceutical companies.
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