Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity with or without type 2 diabetes in Japan and Taiwan (REDEFINE 5): a multicentre, randomised, active-controlled, phase 3a trial
Primary result · Estimated mean change in bodyweightResult — go to the resultEstimated treatment difference −6.5 percentage points 95% CI −8.4 to −4.6Authors' conclusion
These findings support the efficacy and safety of cagrilintide-semaglutide for weight management in individuals from east Asia with overweight or obesity, with or without type 2 diabetes.
Study context
- Population
- Adults ≥18 years with BMI ≥27 kg/m² and ≥2 obesity-related complications, or BMI ≥35 kg/m² and ≥1 complication, with or without T2D; 21 sites in Japan and 1 in Taiwanrandomised 1:1
- Participants
- 331 adults
- Comparison
- Cagrilintide-semaglutide vs semaglutide, plus lifestyle intervention
- Cagrilintide-semaglutiden = 164
- Semaglutiden = 167reference
- Primary endpoint
- Relative change in bodyweight from baseline
- Follow-up
- Week 68
Methodological detailsdouble-blind, parallel-group, active-controlled, multicentre, phase 3a
- Double-blind
- Parallel-group
- Active-controlled
- Multicentre
- Phase 3a
Primary result
Estimated mean change in bodyweight · baseline to week 68
Estimated treatment difference
−6.5 percentage points
95% CI −8.4 to −4.6
P < 0.0001
Change by group
Cagrilintide-semaglutide
−18.4
mean · SE 0.7 · %
Semaglutide
−11.9
mean · SE 0.7 · %
Cagrilintide-semaglutidevs Semaglutide
estimated treatment difference −6.5 percentage points (95% CI −8.4 to −4.6); P < 0.0001
As reported in the abstract
Further findings
- Death · not judged treatment related by the investigator — Semaglutide
- 1 events
Safety
Adverse events
Gastrointestinal disorders · most common adverse events
Discontinuation of treatment
Original publication
Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity with or without type 2 diabetes in Japan and Taiwan (REDEFINE 5): a multicentre, randomised, active-controlled, phase 3a trial. Lancet Diabetes Endocrinol. Published 17 April 2026. doi:10.
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