Compound monograph · §4

Cagrilintide — safety

Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.

Document identifier: CEI-MN-005/4
Series: Compound monograph
Version: 4.3
Published: 06 Nov 2023
Last reviewed: 06 Feb 2025
Next review: 06 Feb 2027
Identifier: 10.71829/cei.mono.5
Certainty: Moderate
Cycle: 2023 Q4

§4Safety

§4.1Adverse events reported in controlled trials

Table 4. Adverse events for Cagrilintide 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	36.0	15.0	+21.0	Phase 2 dose-finding (4.5 mg)
Vomiting	15.0	4.0	+11.0	Phase 2 dose-finding
Constipation	18.0	9.0	+9.0	Phase 2 dose-finding
Injection-site reaction	9.0	2.0	+7.0	Phase 2 dose-finding
Discontinuation for adverse events	6.0	3.0	+3.0	Phase 2 dose-finding
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.

Figure 4. Gastrointestinal adverse events for Cagrilintide as reported in the contributing safety tables. Incidences of this kind are dose- and titration-rate-dependent and attenuate with continued exposure in most but not all participants.

§4.2Contraindications

Not established — investigational compound

§4.3Warnings and precautions

Amylin analogues delay gastric emptying and can precipitate hypoglycaemia when combined with insulin
The long-term consequences of sustained calcitonin receptor agonism, including effects on bone turnover, are uncharacterised

§4.4What this section does not establish

What this document does not establish

Rare events. A trial programme of the size available for this compound could not detect an event occurring at a rate below approximately one in several hundred exposed participants. The absence of such an event in the tables above is uninformative, not reassuring.
Long-latency events. The longest randomised exposure in the contributing evidence is measured in months to a small number of years. Outcomes with a longer latency are outside what any contributing trial could observe.
Harms of the supplied material as distinct from the compound. Every incidence above was measured in a trial using material manufactured under a regulated quality system. Harms attributable to impurities, counter-ion load, endotoxin or incorrect content in research-supply material are not represented in any of these figures.

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.

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
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

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.

Compound Evidence Institute · CEI-MN-005/4 · https://compoundevidence.com/monographs/cagrilintide/safety/ · retrieved 30 July 2026