CagriSema and semaglutide · 68 weeks
REDEFINE 1
CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg, once weekly) reduced weight by 20.4% at 68 weeks, compared with 3.0% on placebo.
Randomized controlled trial
REDEFINE 5: CagriSema vs semaglutide in Japan and Taiwan
At 68 weeks, weight fell by 18.4% on CagriSema and 11.9% on semaglutide 2.4 mg alone; the estimated difference was −6.5 percentage points (95% CI, −8.4 to −4.6; p < 0.0001).
Yamauchi T et al. 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. The Lancet Diabetes & Endocrinology, 2026. DOI: 10.1016/S2213-8587(25)00402-4
- Prepared by
- Alex Gonzalez
- Last updated
- Next review
- Sources
- 3 sources
No clinical review. No advertising from drug companies and no affiliate links.How we work
Key facts
- Drugs
- CagriSema and semaglutide
- Design
- Randomized controlled trial
- Participants
- 331
- Duration
- 68 weeks
- Funding
- Novo Nordisk
- Registry
- NCT05813925
- Population
- 331 adults in Japan and Taiwan with overweight or obesity by Japanese criteria (a BMI of 27 or more with at least two obesity-related complications, or 35 or more with at least one), with or without type 2 diabetes, at 21 sites in Japan and one in Taiwan: 164 assigned to CagriSema and 167 to semaglutide 2.4 mg alone. Of the participants, 68% were men and 24% had type 2 diabetes.
- Primary outcome
- Percentage change in body weight at 68 weeks with CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg, once weekly) versus semaglutide 2.4 mg alone, both with lifestyle changes and double-blind.
What it found
At 68 weeks, weight fell by 18.4% on CagriSema and 11.9% on semaglutide 2.4 mg alone; the estimated difference was −6.5 percentage points (95% CI, −8.4 to −4.6; p < 0.0001). The main analysis used the trial product estimand, which assumes everyone took the treatment as intended, so these figures are not comparable with those of REDEFINE 1. Treatment was stopped by 10% on CagriSema and 6% on semaglutide. Adverse events occurred in 87% and 84%, mostly digestive (53% and 51%); there was one death in the semaglutide group, which the investigator did not attribute to treatment.
Limitations
Funded by Novo Nordisk, which makes CagriSema and semaglutide. It only included people in Japan and Taiwan, using the Japanese obesity criteria. The main analysis assumes everyone stayed on treatment, so it gives larger figures than the treatment-regimen estimand other trials use. There was no placebo group. The product was not approved in any country as of the review date.
What it means for you
A single study is rarely enough to draw conclusions about a particular person: its results are averages from a selected group that was closely monitored. If this topic affects you, these figures are a good starting point for a conversation with your doctor.
Further reading
- How Much Weight Do People Lose on Ozempic, Wegovy or Zepbound? Trial Data
- Ozempic vs Mounjaro (and Zepbound): Real Differences From the Trials and Labels
- What Happens When You Stop Ozempic, Wegovy or Zepbound: Weight Regain, Explained
- CagriSema drug page
- Semaglutide guide
- GLP-1 drug pages
- All study summaries
- Original paper: doi.org/10.1016/S2213-8587(25)00402-4
Sources
The original paper and the records consulted for this summary, with the date they were accessed.
- The Lancet Diabetes & Endocrinology.Yamauchi T, et al. 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). Lancet Diabetes Endocrinol. 2026;14(6):450-462.accessed .
- National Library of Medicine (PubMed).PubMed record PMID 42009015 (abstract).accessed .
- ClinicalTrials.gov (National Library of Medicine).ClinicalTrials.gov record NCT05813925 (REDEFINE 5: registration, eligibility and enrollment).accessed .