Danuglipron in obesity and overweight in adults — evidence extract
The Institute's graded assessment of Danuglipron 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
- Danuglipron, oral, twice daily in the phase 2b programme
- 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 Danuglipron in obesity and overweight in adults.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| DANU-PH2B-OBESITY | 2b | Randomised, double-blind, placebo-controlled | 605 | 32 weeks | 2023 |
§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 | Too few contributing studies for a formal assessment; the risk cannot be excluded. |
| 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.
- Saxena AR, Frias JP, Brown LS, Gorman DN, Vasas S, Tsamandouras N, Birnbaum MJ. Efficacy and safety of oral small molecule glucagon-like peptide 1 receptor agonist danuglipron for glycemic control among patients with type 2 diabetes: a randomized clinical trial. JAMA Network Open 2023;6(5):e2314493. doi:10.1001/jamanetworkopen.2023.14493 · PMID 37237090
- 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
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. ICH Harmonised Guideline 2023;Step 4 version. identifier not held by the Institute
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.