Public comment period · §3
Draft monograph: Semaglutide, oral — disposition
The disposition of every submission and the amendments that resulted.
§3Disposition and amendments
§3.1Disposition table
Table 1. Every submission with its disposition. Each row links to the submission in full.
| Reference | Respondent | Point raised | Disposition |
|---|---|---|---|
| DRAFT-ORAL-SEMAGLU/005 | Leonhard Achterberg | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials | Accepted |
| DRAFT-ORAL-SEMAGLU/009 | Dr Rurik Underhill-Okafor | The compound is supplied under names the monograph does not list | Accepted |
| DRAFT-ORAL-SEMAGLU/003 | Dr Lorcan Whitmarsh-Obi | Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome evidence should… | Accepted in part |
| DRAFT-ORAL-SEMAGLU/002 | Ms Rhiannon Okoye-Vandergraaf | The indication table mixes approved indications with uses for which the compound is merely supplied | Accepted |
| DRAFT-ORAL-SEMAGLU/001 | Dr Fenella Steenkamp-Ferreira | Declared interests should appear on the document rather than on a separate page | Noted, no amendment |
| DRAFT-ORAL-SEMAGLU/008 | Dr Stellan Cholmondeley-Ade | The document should state what a reader ought to do | Not accepted |
| DRAFT-ORAL-SEMAGLU/007 | Xiomara Fairweather-Duru | Trials are described as terminated where they completed as planned | Accepted in part |
| DRAFT-ORAL-SEMAGLU/004 | Dr Kolawole Isaksen-Balogun | Registered trials that never reported are absent from the monograph | Accepted |
| DRAFT-ORAL-SEMAGLU/006 | Dr Ndidi Ravensworth-Ilunga | Doses are expressed in units that differ between sections | Accepted |
| 9 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 5 | The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission. |
| Accepted in part | 2 | Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined. |
| Noted, no amendment | 1 | The submission raises a point the Institute accepts but that does not require a change to the draft, most often because the draft already states it elsewhere. The location is given in the response. |
| Not accepted | 1 | The submission is not accepted. The secretariat response gives the reason. A submission that is not accepted remains published in full; the Institute does not remove a submission because it disagrees with it. |
§3.3Resulting amendments
- The certainty rating for the principal assessed outcome cannot be traced to the contributing trials — arising from DRAFT-ORAL-SEMAGLU/005. Each assessed outcome now carries its downgrade domains in the summary-of-findings row, with a short statement of the judgement made in each, so that the rating can be checked domain by domain against the contributing trials.
- The compound is supplied under names the monograph does not list — arising from DRAFT-ORAL-SEMAGLU/009. 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.
- Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome… — arising from DRAFT-ORAL-SEMAGLU/003. 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.
- The indication table mixes approved indications with uses for which the compound is merely supplied — arising from DRAFT-ORAL-SEMAGLU/002. The indication table now carries a status column with three values, approved, under investigation and supplied without trial evidence, and the value is stated for every row. Rows in the third category also state that no certainty rating is assigned because…
- Trials are described as terminated where they completed as planned — arising from DRAFT-ORAL-SEMAGLU/007. Trial status now uses a fixed vocabulary defined in the glossary, and where the reason for stopping is not evidenced by a document the Institute holds, the status is recorded as stopped with the reason not established rather than assigned.
- Registered trials that never reported are absent from the monograph — arising from DRAFT-ORAL-SEMAGLU/004. 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.
- Doses are expressed in units that differ between sections — arising from DRAFT-ORAL-SEMAGLU/006. 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.
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.
- 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.
Compound Evidence Institute · CEI-CP-069/3 · https://compoundevidence.com/comment-periods/draft-oral-semaglutide-monograph/disposition/ · retrieved 30 July 2026