Novo Nordisk is planning a new Phase III trial for CagriSema, the company’s next-generation obesity drug touted as a potential successor to Wegovy (semaglutide), as the company aims to quell uncertainty over the therapy’s efficacy ceiling.
The Danish drugmaker plans to conduct the trial, called REDEFINE 11, with a longer duration and focus on dose escalation and reescalation. Announcing the trial in a Q4 earnings call for 2024 to investors, Novo’s executive vice president of development Martin Holst Lange said the study is slated to begin in the first half 2025, with the company expecting to submit the CagriSema package to regulatory authorities in the first half of 2026.
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CagriSema combines the GLP-1 receptor agonist (GLP-1RA) semaglutide, used in blockbuster weight-loss drug Wegovy, with dual amylin and calcitonin receptor agonist cagrilintide.
This roadmap comes six weeks after Novo released data from the Phase III REDEFINE 1 trial (NCT05669755) that fell short of the company’s expectations. Despite hitting its primary endpoints, patients on CagriSema achieved a weight loss of 22.7% compared to a reduction of 16.1% with semaglutide or 11.8% with cagrilintide after 68 weeks. Novo had set a 25% weight loss reduction as a goal for the experimental drug.
“While the 25% weight loss was not observed in REDEFINE 1, we are encouraged by the weight loss profile of CagriSema, which stands out as one of the most substantial weight reductions observed in a clinical Phase IIIa trial,” Lange said in the earnings call.
Novo said that the trial’s flexible design – meaning that patients could scale their dosing based on side effects – meant that the weight loss seen after 68 weeks might not have been the ceiling of the drug’s potential. In the high-dose subgroup by the end of the follow-up, weight loss had not started to plateau. “This suggests that additional weight loss could be achieved with a trial of longer duration,” Lange explained.
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By GlobalDataAdditionally, the company said data from the lower dose sub-group indicates that “higher doses through increased focus on dose escalation, dose reescalation, as well as longer treatment duration” could lead to higher weight loss.
In the meantime, eyes will be on the ongoing REDEFINE 2 trial – expected to read out in Q1 this year. A 68-week Phase III study like REDEFINE 1, REDEFINE 2 is evaluating CagriSema in type 2 diabetes patients who are also either obese or overweight.
Novo Nordisk’s CEO Lars Fruergaard Jorgensen said the company “remains confident in [CagriSema’s] potent biology and looks forward to further exploring its potential and to making it available to patients.”
There is a lot riding on CagriSema as Novo Nordisk aims to quell the erosion of its GLP-1RA market share by Eli Lilly’s Mounjaro (tirzepatide). Mounjaro has demonstrated higher weight loss in head-to-head trials and is expected to outsell Wegovy by nearly $15bn by 2030.
Novo reported total sales of $42bn for 2024, up 26% over 2023. Sales of Wegovy soared 86% higher than 2023, reaching sales of $8.4bn. Shares in the Copenhagen-listed company rose 6% at market open following the Q4 results. Novo Nordisk has a market cap of $2.7trn.
