Study wrapper · #779
Cagrilintide-semaglutide (CagriSema) as an add-on to basal insulin in adults with type 2 diabetes (REIMAGINE 3): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study.
Editor's note
REIMAGINE 3 is a double-blind, placebo-controlled Phase 3a trial (274 adults, six countries) testing once-weekly cagrilintide-semaglutide (CagriSema) added to basal insulin in type 2 diabetes. Researchers reported HbA1c reductions of -2.33% (2.4 mg each) and -2.10% (1.0 mg each) versus -0.66% for placebo, meeting the primary endpoint, alongside 10-12% bodyweight reductions and no additional hypoglycaemia; adverse events were mostly mild-to-moderate gastrointestinal, and one unrelated death (malignancy) occurred. Note this is a combination of cagrilintide with semaglutide, not semaglutide alone, so the effect cannot be attributed to semaglutide by itself. The design is strong (randomised, masked, active insulin background), and the result is clear and clinically meaningful over 40 weeks. Longer-term durability and the semaglutide-versus-combination contribution remain open questions. Sponsor: Novo Nordisk.
Plain-language abstract
This trial tested CagriSema, a weekly injection combining semaglutide with another hormone-based drug, cagrilintide, added on top of once-daily background insulin in adults with type 2 diabetes. Over 40 weeks, 274 people were randomly assigned to a higher combination dose, a lower combination dose, or a dummy (placebo) injection, and neither patients nor staff knew who got what. Both combination doses lowered long-term blood sugar (HbA1c) far more than placebo and led to 10-12% weight loss, without extra episodes of dangerously low blood sugar. Side effects were mostly mild or moderate stomach and gut symptoms; there was one death, from cancer, judged unrelated to treatment. Because the drug is a combination, the results reflect the pair together, not semaglutide on its own. The trial was funded by the maker, Novo Nordisk.