Most unapproved peptides have no meaningful human data. Cagrilintide is the exception. Its Phase III programme enrolled thousands of participants, with results published in the New England Journal of Medicine and The Lancet family.
But "complete data" does not mean "simple conclusions." Here is the trial-by-trial breakdown.
[REDEFINE 1: monotherapy vs combination baseline]
This is the core trial. 3,417 adults with obesity or overweight and no diabetes were randomised to CagriSema, semaglutide alone, cagrilintide alone, or placebo for 68 weeks.
Results: CagriSema 20.4%, semaglutide 14.9%, cagrilintide alone 11.5%, placebo 3.0%. Among treatment-completers, CagriSema reached 22.7% (Garvey et al., 2025, NEJM, PMID 40544433).
Two takeaways: cagrilintide monotherapy performs like liraglutide, not like tirzepatide; its value lies in combination.
[REDEFINE 2: type 2 diabetes population]
1,206 adults with type 2 diabetes, CagriSema vs placebo, 68 weeks. Weight loss 13.7% vs 3.4%; 73.5% of participants reached HbA1c of 6.5% or lower (Davies et al., 2025, NEJM, PMID 40544432).
Weight loss in diabetes populations is consistently lower than in non-diabetes populations — a pattern common to GLP-1 drugs, not unique to cagrilintide.
[REIMAGINE 2: head-to-head with semaglutide]
2,713 adults with type 2 diabetes, CagriSema vs semaglutide alone vs cagrilintide alone, 68 weeks. HbA1c fell 1.91 percentage points vs 1.75 for semaglutide alone (Buse et al., 2026, PMID 42251859).
The difference is real but modest. Adverse event rates were 86.9% and 81.2% respectively — the combination adds tolerability cost.
[REDEFINE 4: the trial that lost to tirzepatide]
809 adults with obesity, CagriSema vs tirzepatide 15 mg, open-label, 84 weeks. Result: 23.0% vs 25.5%, failing the non-inferiority endpoint. Announced by Novo Nordisk on 23 February 2026, not yet formally published.
This is the only direct obesity comparison between CagriSema and tirzepatide, and it lost.
[Two new readouts, September 2026]
REIMAGINE 5: adults with type 2 diabetes, CagriSema 1 mg / 1 mg vs tirzepatide 5 mg, 60 weeks. Weight loss 12.4% vs 9.1%, HbA1c non-inferior.
REDEFINE 9: adults without diabetes, CagriSema 1 mg / 1 mg vs placebo, 68 weeks. 21% vs 2%.
Both are company announcements, not yet formally published. The lower-dose regimen (1 mg / 1 mg) is the focus here, suggesting Novo Nordisk is exploring lower doses to improve tolerability.
[A 2026 meta-analysis]
Pooling placebo-controlled trials, cagrilintide monotherapy produced 6.08 percentage points more weight loss than placebo and lowered blood pressure, but had no significant effect on HbA1c on its own (Yaseen et al., 2026, PMID 42583410).
That is the real monotherapy picture: modest weight loss, some blood pressure benefit, weak glycaemic effect.
[What else to keep in mind]
First, every human trial above was funded by Novo Nordisk. That is normal for an investigational drug, but it also means independent replication is lacking.
Second, REDEFINE 4, REIMAGINE 5 and REDEFINE 9 currently exist only as company earnings summaries, not peer-reviewed papers. Treat those numbers with caution until publication.
Third, no trial has ever tested cagrilintide plus retatrutide. That combination has rat data only.