CagriSema (cagrilintide with semaglutide) — safety
Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.
§4Safety
§4.1Adverse events reported in controlled trials
Table 4. Adverse events for CagriSema (cagrilintide with semaglutide) as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.
| Event | Active, % | Comparator, % | Difference, pp | Source |
|---|---|---|---|---|
| Nausea | — | — | — | Combination gastrointestinal burden is broadly the sum of the component profiles rather than additive beyond it |
| Vomiting | — | — | — | Reported at higher incidence than semaglutide monotherapy in cross-trial comparison, which the Institute notes is not a randomised comparison |
| Discontinuation for adverse events | 6.0 | 3.0 | +3.0 | REDEFINE 1 (approximate) |
| A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here. | ||||
§4.2Contraindications
- As for each component
§4.3Warnings and precautions
- All semaglutide warnings apply
- All amylin-class warnings apply
- Because both components delay gastric emptying, the combined effect on gastric residue at anaesthesia has not been quantified
§4.4What this section does not establish
Related assessments: tolerability of incretin receptor agonists · acute pancreatitis · the rodent thyroid C-cell signal.[1,2]
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Frías JP, Deenadayalan S, Erichsen L, Knop FK, Lingvay I, Macura S, Mathieu C, Pedersen SD, Davies M. Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial. The Lancet 2023;402(10403):720–730. doi:10.1016/S0140-6736(23)01163-7 · PMID 37364591
- Lau DCW, Erichsen L, Francisco AM, Satylganova A, le Roux CW, McGowan B, Pedersen SD, Pietiläinen KH, Rubino DM, Batterham RL. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. The Lancet 2021;398(10317):2160–2172. doi:10.1016/S0140-6736(21)01751-7 · PMID 34798060
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