Cagrilintide-Semaglutide in Type 2 Diabetes - CagriSema

Jul 06, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Novo Nordisk
Date Published:
06/23/2023
Date Updated:
07/06/2023
Original Posted Date:
07/06/2023
References

Contribution To Literature:

The CagriSema trial showed that cagrilintide-semaglutide improved glycemic control and weight loss vs. cagrilintide alone.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patients with type 2 diabetes and overweight/obesity were randomized to cagrilintide 2.4 mg–semaglutide 2.4 mg (n = 31) vs. cagrilintide 2.4 mg (n = 30) vs. semaglutide 2.4 mg (n = 31). Study medications were administered by subcutaneous injection weekly.

  • Total number of enrollees: 92
  • Duration of follow-up: 32 weeks
  • Mean patient age: 58 years
  • Percentage female: 36%
  • Percentage with diabetes: 100%

Inclusion criteria:

  • Patients with type 2 diabetes
  • Body mass index ≥27.0 kg/m²
  • Glycated hemoglobin (HbA1c) between 7.5% and 10.0%

Exclusion criteria:

  • Renal impairment
  • Uncontrolled diabetic retinopathy or maculopathy

Principal Findings:

The primary outcome of mean change from baseline in HbA1c was -2.2% in the cagrilintide-semaglutide group vs. -0.9% in the cagrilintide group vs. -1.8% in the semaglutide group in the control group (p < 0.0001 for cagrilintide vs. cagrilintide-semaglutide; p = 0.075 for semaglutide vs. cagrilintide-semaglutide).

Secondary outcomes:

  • Body weight: mean change from baseline: -15.6% in the cagrilintide-semaglutide group vs. -8.1% in the cagrilintide group vs. -5.1% in the semaglutide group in the control group (p < 0.0001 for cagrilintide vs. cagrilintide-semaglutide; p < 0.0001 for semaglutide vs. cagrilintide-semaglutide)
  • Adverse events: 68% in the cagrilintide-semaglutide group vs. 80% in the cagrilintide group vs. 71% in the semaglutide group

Interpretation:

Among patients with type 2 diabetes and overweight/obesity, cagrilintide-semaglutide improved glycemic control and weight loss. This was seen for the study medication versus cagrilintide alone, but not for the study medication versus semaglutide alone. This study medication had an acceptable safety profile. This exploratory trial supports the further investigation of this combination agent in phase 3 studies.

References:

Frias JP, Deenadayalan S, Erichsen L, et al. Efficacy and safety of co-administered once-weekly cagrilintide 2.4 mg with once-weekly semaglutide 2.4 mg in type 2 diabetes: a multicenter, randomized, double-blind, active-controlled, phase 2 trial. Lancet 2023;Jun 23:[Epub ahead of print].

Editorial Comment: Apovian CM, McDonnell ME. CagriSema and the link between obesity and type 2 diabetes. Lancet 2023;Jun 23:[Epub ahead of print].

Clinical Topics: Diabetes and Cardiometabolic Disease, Prevention

Keywords: Body Mass Index, Diabetes Mellitus, Type 2, Glycated Hemoglobin A, Metabolic Syndrome, Obesity, Overweight, Primary Prevention, Secondary Prevention, Weight Loss


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