Cagrilintide-semaglutide (CagriSema) Phase 3 Trial Explores Efficacy and Safety as Basal Insulin Add-on for Type 2 Diabetes

For individuals with type 2 diabetes (T2D), basal insulin therapy often leads to suboptimal glycaemic control, accompanied by undesirable side effects such as weight gain and an elevated risk of hypoglycaemia. This creates a critical unmet need for adjunctive therapies that can enhance glucose regulation while mitigating these adverse effects. The combination of cagrilintide, an amylin receptor agonist, and semaglutide, a GLP-1 receptor agonist, offers complementary mechanisms that could synergistically improve both glycemic parameters and bodyweight management, addressing the limitations of current basal insulin regimens.

This double-blind, parallel-group, randomised, controlled, phase 3a study (REIMAGINE 3) was conducted across 46 centers in six countries. Researchers enrolled 274 adults with type 2 diabetes (HbA1c 7.0-10.5%) on stable once-daily basal insulin, with or without metformin. Participants were randomly assigned (2:2:1:1) to receive once-weekly subcutaneous cagrilintide 2.4 mg plus semaglutide 2.4 mg, cagrilintide 1.0 mg plus semaglutide 1.0 mg, or dose-matched placebo for 40 weeks. The primary endpoint was the mean HbA1c change from baseline to week 40, with secondary endpoints including changes in bodyweight and safety, including hypoglycaemia events.