CagriSema Significantly Improves Glycemic Control and Weight Loss in Type 2 Diabetes:Lancet
USA: A once-weekly fixed-dose combination of the novel amylin analog cagrilintide and the GLP-1 receptor agonist semaglutide (CagriSema) significantly reduced both blood glucose levels and body weight across diverse populations with type 2 diabetes.
In three phase III, double-blind REIMAGINE trials presented at the American Diabetes Association annual meeting, CagriSema at doses of 2.4 mg or 1.0 mg of each component demonstrated robust efficacy, supporting its potential as a powerful once-weekly treatment option for improving glycemic control while promoting meaningful weight loss in patients with type 2 diabetes.
The findings are from the REIMAGINE 1 trial, a phase 3a, randomized, double-blind, placebo-controlled study published in The Lancet Diabetes & Endocrinology. The study was led by Dr. Vanita R. Aroda from the Department of Medicine at Brigham and Women's Hospital, Harvard Medical School, Boston, USA, along with an international team of researchers.
Type 2 diabetes often remains inadequately controlled despite lifestyle interventions, highlighting the need for effective therapies that address both hyperglycemia and excess weight. To evaluate the potential benefits of CagriSema, researchers conducted the phase 3a REIMAGINE 1 trial across 42 sites in six countries.
The study enrolled adults with type 2 diabetes inadequately controlled by diet and exercise alone. Participants were randomly assigned to receive once-weekly CagriSema (2.4 mg or 1.0 mg of each component) or placebo for 40 weeks. A total of 189 participants were randomized, with a mean baseline HbA1c of 7.8% and a mean BMI of 35.2 kg/m².
The study led to the following findings:
- After 40 weeks, participants receiving CagriSema 2.4 mg achieved a mean HbA1c reduction of 1.8 percentage points, compared with a 0.1 percentage point reduction in the placebo group.
- Participants treated with CagriSema 1.0 mg experienced a mean HbA1c reduction of 1.5 percentage points, with both dose groups showing statistically significant improvements over placebo.
- CagriSema 2.4 mg led to an average body weight reduction of 13.8%, significantly greater than the 1.4% reduction observed with placebo.
- Participants receiving CagriSema 1.0 mg achieved an average weight loss of 11.8%, also significantly exceeding the weight reduction seen with placebo.
- Adverse events were reported in 79% of participants receiving CagriSema 2.4 mg, 75% receiving CagriSema 1.0 mg, and 66% receiving placebo.
- Most adverse events associated with CagriSema were mild to moderate in severity and were primarily gastrointestinal in nature.
- The overall safety profile of CagriSema was consistent with that previously reported for GLP-1 receptor agonists and cagrilintide.
The researchers concluded that both CagriSema dose levels significantly improved HbA1c and reduced body weight compared with placebo in adults with early-stage type 2 diabetes inadequately controlled by diet and exercise. While the study involved a relatively small cohort and a 40-week follow-up period, the findings highlight the potential of once-weekly CagriSema as an effective treatment for improving glycemic control and supporting weight loss in type 2 diabetes.
Reference:
Aroda, V. R., Buzzetti, R., Dalskov, S., Jain, A. B., Larsen, J. H., Mathieu, C., Pratley, R. E., Videmark, A., Watt, T., & Buse, J. B. (2026). Efficacy and safety of once-weekly cagrilintide–semaglutide (CagriSema) in adults with type 2 diabetes inadequately controlled on diet and exercise (REIMAGINE 1): A randomised, double-blind, placebo-controlled, phase 3a study. The Lancet Diabetes & Endocrinology. https://doi.org/10.1016/S2213-8587(26)00126-9
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