Cagrilintide–semaglutide improves glycaemic control in early-stage diabetes

Treatment with the combination of cagrilintide plus semaglutide is safe and efficacious for lowering glycaemic levels in individuals with early-stage type 2 diabetes inadequately controlled with diet and exercise, as shown in the phase IIIa REIMAGINE 1 trial.

REIMAGINE 1 included 189 adults (54 percent male, 78 percent White) who were randomly assigned to receive cagrilintide–semaglutide 2.4 mg each (n=62), cagrilintide–semaglutide 1 mg each (n=63), or placebo (n=64). Treatment was administered subcutaneously once a week for 40 weeks.

The primary endpoint was change in HbA_1c from baseline to week 40, while the secondary endpoint was change in bodyweight. Safety was also assessed.

At baseline, the mean HbA_1c was 7.8 percent, and their mean BMI was 35.2 kg/m². Over 40 weeks of treatment, mean HbA_1c decreased by 1.8 percentage points with cagrilintide–semaglutide 2.4 mg and by 1.5 percentage points with cagrilintide–semaglutide 1 mg vs only a reduction of 0.1 percentage points with placebo (estimated treatment difference, −1.7 percentage points and −1.3 percentage points, respectively; p<0.0001 for both).

Additionally, the reductions in bodyweight at week 40 were greater with cagrilintide–semaglutide: −13.8 percent with the 2.4-mg dose and –11.8 percent with the 1-mg dose vs −1.4 percent with placebo (estimated treatment difference, −12.4 percentage points and −10.4 percentage points, respectively; p<0.0001).

In terms of safety, adverse events (AEs) occurred in 79 percent of participants treated with cagrilintide–semaglutide 2.4 mg, 75 percent of those treated with cagrilintide–semaglutide 1 mg, and 66 percent of those who received placebo. AEs were mostly mild or moderate in severity and gastrointestinal-related.