Draft monograph: retatrutide
Consultation on the draft monograph for retatrutide, a triple agonist at the glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide and glucagon receptors. The principal assessed outcome is graded at low certainty because the contributing…
§1Consultation and window
§1.1Window
- Opened
- 27 January 2026
- Closed
- 10 March 2026
- Duration
- 42 days
- Status
- Closed — the disposition is published
- Document under consultation
- Monograph: Retatrutide
- Submissions received
- 14
§1.2Consultation questions
The secretariat put the following questions. A submission was not required to address them and several did not; the questions record what the Institute was uncertain about rather than restricting what a respondent could raise.
- Is the low certainty rating correctly drawn from phase 2 evidence, and is the ongoing phase 3 programme recorded as an evidence gap rather than as supporting evidence?
- Is the mechanistic description of triple agonism proportionate, given that a receptor-occupancy account is not a clinical outcome?
- Does the analytical section give a reader enough to interpret a certificate for a compound with no reference standard in general circulation?
§1.3How a submission is handled
- Every submission is signed. The Institute publishes no anonymous submission.
- Every submission carries a declared interest. A declaration of no interest is itself a declaration and is recorded as one. A declaration is not a disqualification and the Institute has never given a submission less weight on that ground.
- A submission from an employee of a marketing-authorisation holder is identified as an industry submission on its face, following a unanimous consultation on the conflicts policy.
- Every submission receives a secretariat response and a disposition. Submissions that are not accepted remain published in full; the Institute does not remove a submission because it disagrees with it.
- There is no voting, no reputation score, no reply thread and no editing after receipt.
§1.4Outcome
The monograph was amended before ratification. The ongoing phase 3 programme is recorded as an evidence gap with its registered outcome measures listed, and the mechanistic section was shortened and given a statement that receptor pharmacology does not predict clinical effect size.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.