Cagrilintide–semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study
An erratum to this article was published (Lancet Diabetes Endocrinol, Aug 2026 ↗)
Primary result · Mean HbA1c changeResult — go to the resultEstimated treatment difference −0.16 percentage points 95% CI −0.27 to −0.05Authors' conclusion
Cagrilintide-semaglutide (2.4 mg each) was superior to semaglutide 2.4 mg in reducing HbA1c in participants with type 2 diabetes receiving metformin with or without an SGLT2 inhibitor. The safety profile of cagrilintide-semaglutide was consistent with the GLP-1 receptor agonist class and previous safety data for cagrilintide.
Study context
- Population
- Adults ≥18 years with inadequately controlled T2D (HbA1c 7.0–10.5% [53–91 mmol/mol]) on metformin with or without an SGLT2i, BMI ≥25 kg/m²; mean baseline HbA1c 8.2% (SD 0.9)2,595 completed
- Participants
- 2,713 adults
- Comparison
- CagriSema vs semaglutide 2.4 mg
- Cagrilintide-semaglutide (2.4 mg each)n = 603
- Semaglutide 2.4 mgn = 605reference
- Cagrilintide 2.4 mgn = 152
- Cagrilintide-semaglutide (1.0 mg each)n = 595
- Semaglutide 1.0 mgn = 609
- Placebon = 149
- Primary endpoint
- Change in HbA1c from baseline with cagrilintide-semaglutide (2.4 mg each) vs semaglutide 2.4 mg, full analysis set
- Follow-up
- Week 68
Methodological detailsdouble-blind, placebo-controlled, active-controlled, parallel-group, multinational
- Double-blind
- Placebo-controlled
- Active-controlled
- Parallel-group
- Multinational
Primary result
Mean HbA1c change
Estimated treatment difference
−0.16 percentage points
95% CI −0.27 to −0.05
P = 0.0035
Change by group
Cagrilintide-semaglutide (2.4 mg each)
−1.91
mean · SE 0.04 · percentage points
Semaglutide 2.4 mg
−1.75
mean · SE 0.04 · percentage points
As reported in the abstract
Safety
| Outcome | Values |
|---|---|
| Adverse events | Cagrilintide-semaglutide (2.4 mg each) 86.9% · Semaglutide 2.4 mg 81.2% · Cagrilintide 2.4 mg 82.2% · Cagrilintide-semaglutide (1.0 mg each) 81.6% · Semaglutide 1.0 mg 78.5% · Placebo 70.5% |
Adverse events
- Most common AEs in active treatment groups were gastrointestinal disorders
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →