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
Authors' conclusion
Cagrilintide-semaglutide at doses of 2.4 mg each and 1.0 mg each met the primary endpoint, with statistically significant and clinically relevant HbA1c reductions versus placebo when added to basal insulin-treated type 2 diabetes. These reductions were accompanied by robust bodyweight reduction and no additional risk of hypoglycaemia.
Study context
- Population
- Adults with T2D (HbA1c 7.0–10.5%) on stable once-daily basal insulin ± metformin, 46 centres in six countries; mean baseline HbA1c 8.8% (SD 1.0), 58% malerandomised 2:2:1:1
- Participants
- 274 adults
- Comparison
- Once-weekly cagrilintide–semaglutide (2.4 mg each or 1.0 mg each) vs placebo as add-on to basal insulin
- CagriSema 2.4 mg eachn = 90
- CagriSema 1.0 mg eachn = 93
- Placebon = 91reference
- Primary endpoint
- Mean HbA1c change (percentage points) from baseline in all randomised participants
- Follow-up
- Week 40
Methodological detailsdouble-blind, parallel-group, placebo-controlled, multicentre, phase 3a
- Double-blind
- Parallel-group
- Placebo-controlled
- Multicentre
- Phase 3a
Primary result
As reported in the abstract
HbA1c change from baseline
Cagrilintide-semaglutide (2.4 mg each)
−2.33
mean · SE 0.08 · %
Cagrilintide-semaglutide (1.0 mg each)
−2.10
mean · SE 0.08 · %
Placebo
−0.66
mean · SE 0.11 · %
Each group vs placeboEstimated treatment difference, percentage points (95% CI)P value
Cagrilintide-semaglutide (2.4 mg each)
−1.68(−1.95 to −1.41)
P < 0.0001Cagrilintide-semaglutide (1.0 mg each)
−1.44(−1.71 to −1.17)
P < 0.0001Secondary outcomes
| Outcome | Values |
|---|---|
| Death | Cagrilintide-semaglutide (1.0 mg each) 1 events |
Bodyweight change
- Cagrilintide-semaglutide provided bodyweight reductions
- 10-12%
Death
- Death not related to treatment (malignancy)
Safety
- Adverse events — Placebo
- 71%
- Adverse events: Cagrilintide-semaglutide (2.4 mg each) 80%
- Adverse events: Cagrilintide-semaglutide (1.0 mg each) 71%
Adverse events
- Mostly mild or moderate gastrointestinal disorders
Severe hypoglycaemia
- No severe hypoglycaemia was reported
Original publication
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. Lancet. Published 7 June 2026. doi:10.
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