Ecnoglutide — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Obesity and overweight in adults
Anchor outcome. Percentage change in body weight from baseline.
Effect as recorded. −13.2 % body weight at 48 weeks with the highest dose versus −0.5 % with placebo in a Chinese phase 3 trial; estimated difference −12.7 percentage points (95 % CI −14.5 to −10.9).[1,2]
Certainty. Low certainty Downgraded for geographic indirectness and because the Institute could not verify the primary publication against an independent record at this cycle.
Contributing trials. ECNO-PH3-CN-OBESITY. Full structured abstracts are published for each.
Full evidence extract for obesity and overweight in adults · Indication assessment
§3.2Type 2 diabetes mellitus
Anchor outcome. Change in HbA1c (%, mmol/mol).
Effect as recorded. −1.8 % HbA1c reported at 24 weeks; reported without full confidence-interval disclosure in the sources available to the Institute.[2,3]
Certainty. Very low certainty Reporting incompleteness is itself the reason for the rating.
Contributing trials. ECNO-PH3-CN-T2D. Full structured abstracts are published for each.
Full evidence extract for type 2 diabetes mellitus · 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.
- 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
- Müller TD, Finan B, Bloom SR, D’Alessio D, Drucker DJ, Flatt PR, Fritsche A, Gribble F, Grill HJ, Habener JF, Holst JJ, Langhans W, Meier JJ, Nauck MA, Perez-Tilve D, Pocai A, Reimann F, Sandoval DA, Schwartz TW, Seeley RJ. Glucagon-like peptide 1 (GLP-1). Molecular Metabolism 2019;30:72–130. doi:10.1016/j.molmet.2019.09.010 · PMID 31767182
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;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.