Novo Nordisk aims to beat its own blockbuster

Two incarnations of Novo Nordisk’s GLP-1 agonist semaglutide are forecast to be the diabetes and obesity market leaders starting this year. But the Danish group, well aware of Lilly and other competitors’ efforts to fight back, is trying to build on sema’s legacy by combining it with the novel amylin analogue cagrilintide. And early data are encouraging. Today Novo reported results from a phase 2 study, in 92 patients with type 2 diabetes and overweight, pitting Cagrisema, as the combo is known, against its two constituents. After eight months of treatment the combo performed numerically better than either of its parts alone on both blood sugar reduction and weight loss, with the marked improvement over sema on the latter measure particularly eye-catching. Onwards, then, to phase 3: a study in overweight and obese people, Redefine, was already set to start at the end of this year, with Novo targeting weight loss of at least 25%. Novo now says it will begin a late-stage type 2 diabetes programme next year. A glance at what Lilly's GIP/GLP-1 Mounjaro has shown in its indication-specific phase 3 studies shows the bars Cagrisema will have to clear.

Cross-trial comparison of Novo's Cagrisema vs Lilly's Mounjaro
Trial  Unnamed ph2 (NCT04982575)* Surpass-1 (ph3 in type 2 diabetes; NCT03954834)**
Project and dose Cagrilintide 2.4mg Semaglutide 2.4mg CagriSema (cagri 2.4mg + sema 2.4mg) Mounjaro 5-15mg
Reduction in HbA1c (percentage points) 0.9 1.8 2.2 1.7-1.8
Trial  Unnamed ph2 (NCT04982575)* Surmount-1 (ph3 in obesity; NCT04184622)^
Bodyweight reduction (%) 8.1 5.1 15.6 15.0-20.9
*Data at 32wk. **Data at 40wk. ^Data at 72wk. Mounjaro efficacy data are treatment-regimen estimands. Source: Company releases, NEJM. 


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