Danuglipron — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Type 2 diabetes mellitus
Anchor outcome. Change in HbA1c (%, mmol/mol).
Effect as recorded. −1.16 % HbA1c at 16 weeks with 120 mg twice daily versus placebo; estimated difference −1.16 % (95 % CI −1.55 to −0.77).[1,2]
Certainty. Moderate certainty Phase 2b; efficacy was established but did not exceed the injectable class.
Contributing trials. DANU-PH2B-T2D. Full structured abstracts are published for each.
Full evidence extract for type 2 diabetes mellitus · Indication assessment
§3.2Obesity and overweight in adults
Anchor outcome. Percentage change in body weight from baseline.
Effect as recorded. −8.0 to −13.0 % body weight at 32 weeks across doses, with discontinuation rates above 50 % in some arms; wide; high attrition compromises the estimate.[2,3]
Certainty. Low certainty Downgraded two levels: attrition above 50 % in the higher-dose arms makes the treatment-policy estimate unreliable.
Contributing trials. DANU-PH2B-OBESITY. Full structured abstracts are published for each.
Full evidence extract for obesity and overweight in adults · Indication assessment
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
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