Lixisenatide in obesity and overweight in adults — evidence extract
The Institute's graded assessment of Lixisenatide for obesity and overweight in adults, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Obesity and overweight in adults
§1.1Question and anchor outcome
- Population
- Excess adiposity sufficient to impair health, operationalised in the pivotal incretin programmes as a body-mass index of 30 kg/m² or above, or 27 kg/m² or above with at least one weight-related comorbidity.
- Intervention
- Lixisenatide, subcutaneous once daily before the first meal of the day
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Percentage change in body weight from baseline
Additional outcomes the Institute extracts for this indication: Proportion achieving ≥5 %, ≥10 %, ≥15 % and ≥20 % weight reduction; Change in waist circumference; Change in systolic blood pressure; Change in high-sensitivity C-reactive protein.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Lixisenatide in obesity and overweight in adults.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| GETGOAL-M | 3 | Randomised, double-blind, placebo-controlled | 680 | 24 weeks | 2013 |
§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 | Serious | An outcome that would answer the question was not measured in any contributing trial. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: Moderate certainty. The true effect is likely to be close to the estimate, but there is a possibility that it is substantially different. Further research is likely to have an important impact on confidence in 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.
- Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Køber LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. New England Journal of Medicine 2015;373(23):2247–2257. doi:10.1056/NEJMoa1509225 · PMID 26630143
- Drucker DJ. Mechanisms of action and therapeutic application of glucagon-like peptide-1. Cell Metabolism 2018;27(4):740–756. doi:10.1016/j.cmet.2018.03.001 · PMID 29617641
- Nauck MA, Quast DR, Wefers J, Meier JJ. GLP-1 receptor agonists in the treatment of type 2 diabetes — state-of-the-art. Molecular Metabolism 2021;46:101102. doi:10.1016/j.molmet.2020.101102 · PMID 33068776
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.