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Cagrilintide + Semaglutide in Type 2 Diabetes

In a trial of participants with type 2 diabetes, coadministered once-weekly semaglutide with the long-acting amylin analog cagrilintide (CagriSema) produced clinically relevant improvements in glycemic control, according to company-sponsored phase 2 trial results. “The mean change in HbA1c with CagriSema was greater versus cagrilintide, but not versus semaglutide,” the authors conclude. “Treatment with CagriSema resulted in significantly greater weight loss versus semaglutide and cagrilintide and was well tolerated. These data support further investigation of CagriSema in this population in longer and larger phase 3 studies.”

Participants were adults at 17 U.S. sites with type 2 diabetes and a BMI of 27 or higher while on metformin with or without an SGLT2 inhibitor. Random assignment to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2.4 mg) had these effects on a primary endpoint of change in HbA1c levels: “The mean change in HbA1c from baseline to week 32 (CagriSema: –2.2 percentage points [SE 0.15]; semaglutide: –1.8 percentage points [0.16]; cagrilintide: –0.9 percentage points [0.15]) was greater with CagriSema versus cagrilintide (estimated treatment difference –1.3 percentage points [95% CI –1.7 to –0.8]; P <0.0001), but not versus semaglutide (–0.4 percentage points [–0.8 to 0.0]; P = 0.075). The mean change in bodyweight from baseline to week 32 (CagriSema: –15.6% [SE 1.26]; semaglutide: –5.1% [1.26]; cagrilintide: –8.1% [1.23]) was greater with CagriSema versus both semaglutide (P <0.0001) and cagrilintide (P <0.0001). The mean change in fasting plasma glucose from baseline to week 32 (CagriSema: –3.3 mmol/L [SE 0.3]; semaglutide: –2.5 mmol/L [0.4]; cagrilintide: –1.7 mmol/L [0.3]) was greater with CagriSema versus cagrilintide (P = 0.0010) but not versus semaglutide (P = 0.10). Time in range (3.9–10.0 mmol/L) was 45.9%, 32.6%, and 56.9% at baseline and 88.9%, 76.2%, and 71.7% at week 32 with CagriSema, semaglutide, and cagrilintide, respectively. Adverse events were reported by 21 (68%) participants in the CagriSema group, 22 (71%) in the semaglutide group, and 24 (80%) in the cagrilintide group. Mild or moderate gastrointestinal adverse events were most common; no level 2 or 3 hypoglycaemia was reported. No fatal adverse events were reported.”

Source: Lancet