Draft monograph: tirzepatide, version 2 — disposition

§3Disposition and amendments

§3.1Disposition table

Table 1. Every submission with its disposition. Each row links to the submission in full.

§3.2Summary by disposition

Table 2. Counts by disposition, with the meaning of each.

§3.3Resulting amendments

1. Local reactions are omitted from the adverse-event table because the trials reported them separately — arising from DRAFT-TIRZEPATIDE-/001. Local reactions are now carried in the adverse-event table wherever the source trials report them, footnoted with the convention each trial used.
2. Effect estimates are given without naming the comparator — arising from DRAFT-TIRZEPATIDE-/002. The comparator is now stated in every outcome row, and estimates against different comparators are reported in separate tables with the comparator named in the table caption.
3. The analytical section assumes a reference standard that is not generally available — arising from DRAFT-TIRZEPATIDE-/003. The analytical section now states whether a reference standard is in general circulation for this compound and, where it is not, states which determinations remain possible and which become qualitative. A content figure obtained without a reference standard…
4. The recorded evidence gaps omit outcomes a reader would consider material — arising from DRAFT-TIRZEPATIDE-/005. The evidence-gap section is now derived from the anchor and decision-relevant outcomes for the indication, and any such outcome measured by no contributing trial is recorded as not measured rather than omitted.
5. Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome… — arising from DRAFT-TIRZEPATIDE-/006. Cardiovascular outcomes are now an assessed outcome with their own certainty rating in every monograph for which a dedicated cardiovascular outcome trial of that compound has reported, and are recorded as not assessed elsewhere.
6. The same concept is given three different names in one document — arising from DRAFT-TIRZEPATIDE-/007. A single term is now used throughout for each defined concept, and the glossary entry is linked at first use within each section rather than once per document.
7. The document is unreadable without specialist training — arising from DRAFT-TIRZEPATIDE-/008. Every document now opens with a plain-language summary of not more than 150 words, placed above the technical abstract and carrying the same certainty language, so that the two cannot diverge.
8. Registered trials that never reported are absent from the monograph — arising from DRAFT-TIRZEPATIDE-/009. The trial list now includes every registered trial the Institute identified, with its reporting status stated, and the monograph reports the proportion of registered trials for which no result has been posted or published.
9. What happens to weight after the compound is stopped is not in the assessed outcomes — arising from DRAFT-TIRZEPATIDE-/010. Post-withdrawal trajectory is now an assessed outcome wherever a withdrawal period was studied, rated on the same scale as the others. Where no withdrawal period was studied the outcome is recorded as not assessed.
10. Adverse event frequencies are given without the denominator or the exposure period — arising from DRAFT-TIRZEPATIDE-/011. Every reported frequency now carries the number of participants, the number of events and the exposure period, and comparator-arm figures are reported alongside rather than in a separate table.
11. The compound is supplied under names the monograph does not list — arising from DRAFT-TIRZEPATIDE-/012. The synonym list is extended to include every name the Institute can evidence from a document it holds, each recorded with its source. Names asserted without a supporting document are not added, and the distinction is stated at the head of the list.
12. The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-TIRZEPATIDE-/013. The analytical section is reduced to compound-specific content and cross-references the relevant standards for the general procedure, which shortens it substantially without removing what is not available elsewhere.
13. The interaction section lists mechanisms rather than interactions — arising from DRAFT-TIRZEPATIDE-/015. The interaction section is now divided into interactions reported in clinical use and interactions predicted from mechanism, with the second labelled as prediction. Where neither exists the section says so in one line rather than being padded.

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.

1. International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. 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.