Efficacy and safety of once-weekly cagrilintide–semaglutide (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
Authors' conclusion
In a population of people with early-stage type 2 diabetes inadequately controlled with diet and exercise, cagrilintide-semaglutide (2.4 mg each and 1.0 mg each) was superior to placebo in reducing HbA1c. The safety profile was consistent with the GLP-1 receptor agonist class and previous safety data for cagrilintide.
Study context
- Population
- Adults aged ≥18 years with T2D inadequately controlled with diet and exercise; 54% male, 78% White; baseline mean HbA1c 7.8% (SD 0.7), BMI 35.2 kg/m² (7.4)294 screened
- Participants
- 189 adults
- Comparison
- Once-weekly SC cagrilintide-semaglutide vs placebo for 40 weeks
- Cagrilintide-semaglutide (2.4 mg each)n = 62
- Cagrilintide-semaglutide (1.0 mg each)n = 63
- Placebon = 64reference
- Primary endpoint
- Change in HbA1c from baseline, full analysis set
- Follow-up
- Week 40
Methodological detailsdouble-blind, placebo-controlled, parallel-group, phase 3a, multicentre (42 sites, six countries), stratified by HbA1c <8.5% at screening and MRI substudy participation, Enrolment between March 19 and Dec 5, 2024
- Double-blind
- Placebo-controlled
- Parallel-group
- Phase 3a
- Multicentre (42 sites, six countries)
- Stratified by HbA1c <8.5% at screening and MRI substudy participation
- Enrolment between March 19 and Dec 5, 2024
Primary result
As reported in the abstract
Estimated mean change in HbA1c · 40 weeks
Cagrilintide-semaglutide (2.4 mg each)
−1.8
mean · SE 0.1 · percentage points
Cagrilintide-semaglutide (1.0 mg each)
−1.5
mean · SE 0.1 · percentage points
Placebo
−0.1
mean · SE 0.2 · percentage points
Each group vs placeboEstimated treatment difference, percentage points (95% CI)P value
Cagrilintide-semaglutide (2.4 mg each)
−1.7(−2.0 to −1.3)
P < 0.0001Cagrilintide-semaglutide (1.0 mg each)
−1.3(−1.8 to −0.9)
P < 0.0001Secondary outcomes
Mean, %
| Outcome | Cagrilintide-semaglutide (2.4 mg each) | Cagrilintide-semaglutide (1.0 mg each) | Placebo | Estimated treatment difference (percentage points) (95% CI) | P value | |
|---|---|---|---|---|---|---|
| Estimated mean relative change in bodyweight (prespecified secondary endpoint) · baseline to week 40Cagrilintide-semaglutide (2.4 mg each)vs Placebo | −13.8 (SE 1.0) | −11.8 (SE 1.0) | −1.4 (SE 0.7) | −12.4 (−14.7 to −10.1) | P < 0.0001 | |
| Estimated mean relative change in bodyweight (prespecified secondary endpoint) · baseline to week 40Cagrilintide-semaglutide (1.0 mg each)vs Placebo | −10.4 (−12.9 to −8.0) | P < 0.0001 | ||||
| −20−10010Difference, percentage points (linear scale) |
Safety
Adverse events · safety set: all participants who received at least one dose
Adverse events
- Most adverse events were mild or moderate and gastrointestinal related
Original publication
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. Lancet Diabetes Endocrinol. Published 7 June 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →