Maridebart cafraglutide — 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 Maridebart cafraglutide 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 | — | — | — | High incidence on first dose, attributed to the loading regimen; substantially lower on subsequent doses |
| Vomiting | — | — | — | Reported at high incidence on initiation |
| Injection-site reaction | — | — | — | Reported |
| Discontinuation for adverse events | — | — | — | Concentrated in the first dosing interval |
| 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
- Not established
§4.3Warnings and precautions
- A 21-day half-life means adverse effects cannot be rapidly reversed by discontinuation
- Immunogenicity of an antibody–peptide conjugate over years of exposure is unknown
- Long-term consequences of chronic GIP receptor blockade are unknown
§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.
- Samms RJ, Coghlan MP, Sloop KW. How may GIP enhance the therapeutic efficacy of GLP-1?. Trends in Endocrinology & Metabolism 2020;31(6):410–421. doi:10.1016/j.tem.2020.02.006 · PMID 32396843
- Coskun T, Sloop KW, Loghin C, Alsina-Fernandez J, Urva S, Bokvist KB, Cui X, Briere DA, Cabrera O, Roell WC, Kuchibhotla U, Moyers JS, Benson CT, Gimeno RE, D’Alessio DA, Haupt A. LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: from discovery to clinical proof of concept. Molecular Metabolism 2018;18:3–14. doi:10.1016/j.molmet.2018.09.009 · PMID 30473097
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.