Maridebart cafraglutide in type 2 diabetes mellitus — evidence extract
The Institute's graded assessment of Maridebart cafraglutide for type 2 diabetes mellitus, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Type 2 diabetes mellitus
§1.1Question and anchor outcome
- Population
- A disorder of glucose regulation characterised by insulin resistance with relative insulin deficiency, diagnosed by glycated haemoglobin, fasting plasma glucose or oral glucose tolerance criteria.
- Intervention
- Maridebart cafraglutide, subcutaneous, monthly or less frequently
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Change in HbA1c (%, mmol/mol)
Additional outcomes the Institute extracts for this indication: Proportion achieving HbA1c <7.0 % and ≤6.5 %; Change in fasting serum glucose; Change in body weight; Documented symptomatic hypoglycaemia.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Maridebart cafraglutide in type 2 diabetes mellitus.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| MARITIDE-PH2-T2D | 2 | Randomised, double-blind, placebo-controlled | — | 52 weeks | 2024 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | Very serious | The evidence base is small, recent and wholly sponsor-generated. |
| Overall rating: Low certainty. Confidence in the effect estimate is limited. The true effect may be substantially different from the estimate. | ||
§1.4What this extract does not establish
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
- Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A. Tirzepatide once weekly for the treatment of obesity. New England Journal of Medicine 2022;387(3):205–216. doi:10.1056/NEJMoa2206038 · PMID 35658024
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.