Draft monograph: tirzepatide, version 2
Consultation on the second version of the tirzepatide monograph, which incorporates the obesity evidence from SURMOUNT-1, reported in the New England Journal of Medicine in 2022, the withdrawal evidence from SURMOUNT-4, reported in JAMA in 2024, and the…
§1Consultation and window
§1.1Window
- Opened
- 3 May 2025
- Closed
- 31 May 2025
- Duration
- 28 days
- Status
- Closed — the disposition is published
- Document under consultation
- Monograph: Tirzepatide
- Submissions received
- 15
§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 certainty rating for the weight-reduction outcome correctly drawn from the contributing SURMOUNT trials?
- Is the SURPASS-2 comparison presented in a way that makes plain which semaglutide dose was compared, given that the comparator dose is the most frequently misreported feature of that trial?
- Does the analytical section give a reader enough to interpret a certificate for a dual agonist whose related substances are not separable by a single ultraviolet purity determination?
§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 comparator dose in the SURPASS-2 row is now stated in the row itself rather than in a footnote, and the analytical section carries an explicit statement of what a single purity figure does not establish for this compound.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.