A new phase 3a clinical trial published in The Lancet Diabetes & Endocrinology found that combining cagrilintide with semaglutide produced greater body weight reductions than semaglutide alone in adults living with overweight or obesity — including those with type 2 diabetes — across Japan and Taiwan. The findings add to a growing body of evidence that a dual-hormone approach may push weight loss beyond what GLP-1 therapy can achieve on its own.
What Is the REDEFINE 5 Trial?
REDEFINE 5 is a multicentre, randomised, active-controlled phase 3a trial that enrolled adults with overweight or obesity in Japan and Taiwan. Participants received either a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg, or semaglutide 2.4 mg alone. The study is part of a broader REDEFINE clinical program evaluating the combination — sometimes called CagriSema — across global and regional populations.
Cagrilintide is an amylin analogue, a hormone naturally released by the pancreas alongside insulin. Semaglutide, the active ingredient in Ozempic and Wegovy, is a GLP-1 receptor agonist. By targeting two separate appetite-regulating pathways simultaneously, the combination is designed to produce additive effects on weight reduction.
What the Results Mean for Patients
The trial found that the fixed-dose combination of cagrilintide and semaglutide outperformed semaglutide alone in reducing body weight in this regional population. Importantly, the study included participants both with and without type 2 diabetes, suggesting potential broad applicability across the overweight and obesity spectrum.
For people currently on Wegovy or Ozempic who feel they have hit a plateau, these results are notable. They suggest that adding an amylin-pathway drug to a GLP-1 could unlock additional weight loss — though CagriSema is not yet approved anywhere and is not currently available as a prescription option.
Key takeaway: The REDEFINE 5 trial shows the cagrilintide–semaglutide combination outperformed semaglutide 2.4 mg alone for weight loss in Asian populations, but the drug has not yet received regulatory approval in any market.
What to Watch Next
REDEFINE 5 is one of several trials in the global REDEFINE program. Regulatory submissions for the CagriSema fixed-dose combination would need to be reviewed by agencies such as the FDA, EMA, and regional bodies before the treatment could be prescribed. No approval timeline was specified in the published trial data. Patients and clinicians will want to watch for announcements from Novo Nordisk — the developer of both semaglutide and cagrilintide — regarding regulatory filings and any additional safety data from the broader REDEFINE program.
Frequently Asked Questions
The REDEFINE 5 findings are encouraging, but translating trial data into a treatment decision is personal. If you are curious about combination approaches or feel your current GLP-1 therapy is not meeting your goals, talk with your prescriber about what options — approved or in development — may be appropriate for your situation.
- Peer-reviewed journal article, '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 & Endocrinology, date not specified in source material.