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. Registered trials that never reported are absent from the monograph — arising from DRAFT-TIRZEPATIDE-/005. 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.
2. What happens when the compound is stopped is not addressed — arising from DRAFT-TIRZEPATIDE-/012. Discontinuation trajectory is now an assessed outcome in every monograph where a contributing trial measured it, and a recorded evidence gap in every monograph where none did, so that its absence is visible rather than silent.
3. The document is unreadable without specialist training — arising from DRAFT-TIRZEPATIDE-/006. 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.
4. Doses are expressed in units that differ between sections — arising from DRAFT-TIRZEPATIDE-/003. A single dose unit is now used throughout each monograph, with the source unit retained in parentheses wherever a conversion was applied, and every conversion is stated rather than performed silently.
5. The compound is supplied under names the monograph does not list — arising from DRAFT-TIRZEPATIDE-/004. 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.
6. Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome… — arising from DRAFT-TIRZEPATIDE-/010. 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.
7. The absence of a rare harm in the trial set is presented as reassurance — arising from DRAFT-TIRZEPATIDE-/015. Wherever the monograph reports that an event was not observed, it now states the total exposure and the frequency the contributing trials could have detected, so that the absence is read as the limit of the evidence rather than as a finding.
8. The population to which the headline estimate applies is not stated with the estimate — arising from DRAFT-TIRZEPATIDE-/009. Every headline estimate now carries a one-line statement of the population in which it was observed, and the full eligibility criteria are reported in the included-studies table rather than only in the source.
9. The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-TIRZEPATIDE-/002. 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.
10. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-TIRZEPATIDE-/014. The trial status now reads as completed at a pre-specified interim analysis, with the analysis identified, and the dose is stated in the unit used in the approved labelling. The submission is identified as an industry submission on its face in accordance with…
11. References should carry a persistent identifier for every cited source — arising from DRAFT-TIRZEPATIDE-/007. Every reference without a persistent identifier now carries an explicit statement that the identifier is not held by the Institute, so that its absence is a recorded fact rather than an apparent oversight.

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.