CagriSema is Novo Nordisk's answer to the multi-receptor peptides from Lilly and others. Rather than build one molecule that hits several receptors, it pairs the company's existing GLP-1, semaglutide at 2.4 mg, with a new long-acting analogue of amylin, cagrilintide, also at 2.4 mg, given together once a week.
Mechanism and receptor profile
Two active peptides. Semaglutide is a GLP-1 receptor agonist (94% homology to human GLP-1, per the Ozempic label). Cagrilintide is an analogue of amylin, the beta-cell hormone co-secreted with insulin, which acts on amylin receptors to slow gastric emptying and reduce food intake through a central pathway distinct from GLP-1's. The trials describe the product as co-administered cagrilintide and semaglutide. No label exists, so there is no FDA-reviewed statement of mechanism.
Regulatory status
No application in Drugs@FDA as of 4 September 2026. The REDEFINE phase 3 program published its first two trials in the New England Journal of Medicine in June 2025 and a comparison against semaglutide alone in 2026.
Trials and their numbers
| Trial | Population and duration | Result | PubMed |
|---|---|---|---|
| REDEFINE 1 | 3,417 adults with obesity or overweight plus a weight-related condition, no diabetes; 68 weeks | Weight -20.4% with cagrilintide-semaglutide vs -3.0% placebo (difference -17.3 points, 95% CI -18.1 to -16.6); more participants reached 5%, 20%, 25% and 30% thresholds; gastrointestinal events 79.6% vs 39.9% | 40544433 |
| REDEFINE 2 | 1,206 adults with obesity or overweight and type 2 diabetes; 68 weeks | Weight -13.7% vs -3.4% (difference -10.4 points, 95% CI -11.2 to -9.5); HbA1c 6.5% or lower in 73.5% vs 15.9%; gastrointestinal events 72.5% vs 34.4% | 40544432 |
REDEFINE 1 randomized 2,108 to the combination, 302 to semaglutide alone, 302 to cagrilintide alone and 705 to placebo, so the single-agent arms were small relative to the combination arm. The 2026 Lancet Diabetes and Endocrinology paper is the direct comparison against semaglutide alone; its numbers belong in a trial digest rather than here, and the Research site covers the REDEFINE program.
Adverse events
No label table. From the abstracts: gastrointestinal events (nausea, vomiting, diarrhea, constipation, abdominal pain) in 79.6% against 39.9% on placebo in REDEFINE 1, mainly transient and mild to moderate; 72.5% against 34.4% in REDEFINE 2.
Boxed warning
None; no label exists. Semaglutide's own boxed warning would apply to the semaglutide component if a combination were approved; whether an amylin analogue carries any additional warning is for the review to decide.
Manufacturer
Novo Nordisk funded both trials.
Where next
The semaglutide injection entry has the single-agent baseline (STEP 1, STEP UP at 7.2 mg). The glossary defines amylin and co-formulation.
Questions people ask
What is amylin and why combine it with a GLP-1?
Amylin is a hormone released with insulin from the pancreatic beta cell. It slows gastric emptying and reduces food intake through receptors in the brainstem, a pathway separate from GLP-1's. Cagrilintide is a long-acting amylin analogue; pairing it with semaglutide is meant to add a second appetite signal rather than push one receptor harder.
Did CagriSema beat semaglutide alone?
REDEFINE 1 randomized participants to the combination, semaglutide alone, cagrilintide alone or placebo. The abstract reports the combination at minus 20.4% against minus 3.0% for placebo; the single-agent arm results are in the full paper. Semaglutide 2.4 mg alone produced minus 14.9% in STEP 1, a different trial.
Sources
- Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1). N Engl J Med 2025. PubMed 40544433 Accessed September 4, 2026.
- Cagrilintide-semaglutide in adults with overweight or obesity and type 2 diabetes (REDEFINE 2). N Engl J Med 2025. PubMed 40544432 Accessed September 4, 2026.
- Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity. Lancet Diabetes Endocrinol 2026. PubMed 42009015 Accessed September 4, 2026.
- Drugs@FDA search (no application for CagriSema on 4 September 2026) Accessed September 4, 2026.
Canonical URL: https://formblendsglp1s.com/agents/cagrisema. Written by the FormBlends editorial team. This page is educational and is not medical advice; see the medical disclaimer.