Overview
- In the 68-week REIMAGINE 2 study of 2,728 adults with type 2 diabetes on metformin (mean HbA1c 8.2%; mean weight 101 kg), roughly 40% were also taking an SGLT2 inhibitor.
- Using the efficacy estimand, the fixed-dose cagrilintide 2.4 mg plus semaglutide 2.4 mg combination reduced HbA1c by 1.91 percentage points and cut body weight by 14.2%, versus 1.76 points and 10.2% with semaglutide 2.4 mg alone.
- Under the treatment‑regimen estimand that includes discontinuations or changes, HbA1c fell 1.8 points and weight declined 12.9% with the combination, compared with 1.68 points and 9.2% on semaglutide alone.
- The company reported a generally acceptable safety profile with mostly mild to moderate gastrointestinal events that lessened over time; 43% of participants on the top combination dose lost at least 15% of body weight and 24% lost at least 20%.
- Novo Nordisk has filed for U.S. approval in obesity based on REDEFINE 1 and 2 and plans to seek a diabetes indication after REIMAGINE 1 and REDEFINE 3, while BioPharma Dive noted the regimen-level results rank numerically below Zepbound in similar populations without a head-to-head study.