CagriSema
CagriSema, a peptide. Fixed-dose co-formulation of cagrilintide and semaglutide in equal masses, delivered once weekly from a dual-chamber pen as a single…
Fixed-dose co-formulation of cagrilintide and semaglutide in equal masses, delivered once weekly from a dual-chamber pen as a single subcutaneous injection. The rationale is two non-overlapping satiety mechanisms in one product: amylin-receptor agonism acting through the area postrema and slowing gastric emptying, plus GLP-1 receptor agonism. Phase 3 (REDEFINE 1 and 2, REDEFINE 5, REIMAGINE 2) tests it against each component alone, which is the comparison that matters for a combination.
COMPOSITION IS VERBATIM, twice over: "a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg" (PMID:42009015) and REIMAGINE 2's arm list naming "cagrilintide-semaglutide [2.4 mg each]" and "cagrilintide 1.0 mg plus semaglutide 1.0 mg (hereafter cagrilintide-semaglutide [1.0 mg each])" (PMID:42251859), which is where the 2 mg lower bound of the dose range comes from. ONE INJECTION, NOT TWO, and this is the distinction the record exists to hold: PMID:42366647 describes "the CagriSema dual-chamber pen, a single-dose, single-use, pre-filled autoinjector for once-weekly subcutaneous administration of a fixed-dose combination of cagrilintide and semaglutide". The phase 1b that produced the only human PK for the pair (PMID:33894838) was explicitly "concomitant administration" of separate injections, and REDEFINE 1 still titles it coadministration — so that trial's exposure numbers must NOT be attributed to the pen. WHAT THE EXPANSION ACTUALLY DOES: semaglutide carries authored PK, cagrilintide now carries a half-life and a ka, so a logged 4.8 mg dose splits into 2.4 mg of each and renders two curves. That is the honest behaviour and it is better than a single invented curve, but note the cagrilintide half is only as good as its own record, whose volume is defaulted. Phase 3 references PMID:40544433 (REDEFINE 1, NEJM, NCT05567796), PMID:40544432 (REDEFINE 2, NCT05394519), PMID:42009015 (REDEFINE 5, east Asian population, NCT05813925) and PMID:42251859 (REIMAGINE 2, NCT06065540).
Sources: PMID:42009015, PMID:42251859, PMID:42366647, PMID:40544433, PMID:40544432, PMID:33894838