Efficacy and safety of co-administered cagrilintide–semaglutide (cagrilintide-semaglutide (CagriSema)) 1·7 mg each and 1·0 mg each in adults with overweight or obesity (REDEFINE 9): a multicentre, randomised, double-blind within-dose-level, placebo-controlled, parallel-group, phase 3b trial
Authors' conclusion
Cagrilintide-semaglutide at 1.7 mg each and 1.0 mg each was superior to placebo at reducing bodyweight in adults with overweight or obesity, suggesting that different dose levels might support treatment flexibility.
Study context
- Population
- Adults aged 18 years or older with a BMI of at least 30 kg/m² or at least 27 kg/m² and one or more obesity-related complication, without diabetesrandomly assigned (full analysis set), 308 received at least one dose
- Participants
- 309 adults
- Comparison
- Once per week subcutaneous cagrilintide-semaglutide 1.7 mg each or 1.0 mg each versus placebo
- Cagrilintide-semaglutide 1.7 mg eachn = 104
- Cagrilintide-semaglutide 1.0 mg eachn = 103
- Pooled placebon = 102
- Primary endpoint
- Coprimary: relative mean change in bodyweight from baseline
- Follow-up
- Week 68
Methodological detailsrandomly assigned (2:1:2:1) centrally, block randomisation (block size of six), 24 sites in Canada, France, Germany, the UK, and the USA
- Randomly assigned (2:1:2:1) centrally
- Block randomisation (block size of six)
- 24 sites in Canada, France, Germany, the UK, and the USA
Primary result
As reported in the abstract
Cagrilintide-semaglutide 1.7 mg each
−20.7%
mean · SE 0.9
Cagrilintide-semaglutide 1.0 mg each
−21.0%
mean · SE 1.0
Pooled placebo
−2.0%
mean · SE 1.0
Estimated treatment difference [ETD], percentage points (95% CI)P value
Cagrilintide-semaglutide 1.7 mg eachvs pooled placebo
−18.8(−21.5 to −16.0)
P < 0.0001Cagrilintide-semaglutide 1.0 mg eachvs pooled placebo
−19.0(−21.8 to −16.2)
P < 0.0001Further findings
| Outcome | Cagrilintide-semaglutide 1.7 mg each | Cagrilintide-semaglutide 1.0 mg each | Pooled placebo | ETD (percentage points) (95% CI) | P value | |
|---|---|---|---|---|---|---|
| Coprimary: proportion of participants reaching bodyweight reduction of at least 5% · week 68Cagrilintide-semaglutide 1.7 mg eachvs pooled placeboCoprimary endpoint | 95.1% (SE 2.7) | 96.3% (SE 2.2) | 33.4% (SE 5.6) | 61.7 (49.5–74.0) | P < 0.0001 | |
| Coprimary: proportion of participants reaching bodyweight reduction of at least 5% · week 68Cagrilintide-semaglutide 1.0 mg eachvs pooled placeboCoprimary endpoint | 63.0 (51.1–74.9) | P < 0.0001 | ||||
| −50050100Difference, percentage points (linear scale) |
Study conduct · week 68
- Completed the study
- 291 (94%) of 309
- On treatment at week 68
- 254 (82%)
Safety
Adverse events · safety analysis set
Adverse events
- Most adverse events were mild or moderate and gastrointestinal-related
- No deaths were reported
Original publication
Efficacy and safety of co-administered cagrilintide–semaglutide (CagriSema) 1·7 mg each and 1·0 mg each in adults with overweight or obesity (REDEFINE 9): a multicentre, randomised, double-blind within-dose-level, placebo-controlled, parallel-group, phase 3b trial. Lancet Diabetes Endocrinol. Published 14 November 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →