SURMOUNT-OSA-1 — structured trial abstract
SURMOUNT-OSA-1 — Tirzepatide in sleep apnoea and obesity: randomised, double-blind, placebo-controlled
§1Structured abstract
§1.1Objective
To evaluate Tirzepatide in obstructive sleep apnoea with obesity and obesity and overweight in adults, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Randomised, double-blind, placebo-controlled, parallel-group
- Masking
- Double-blind (participant, investigator and sponsor)
- Phase
- Phase 3
- Randomised participants
- not recorded by the Institute
- Duration of the primary analysis period
- 52 weeks
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Change in the apnoea–hypopnoea index at week 52 in participants not using positive airway pressure therapy
§1.4Principal result
Substantial reduction in the apnoea–hypopnoea index relative to placebo; the Institute reproduces the pooled programme estimate rather than a per-trial figure.
§1.5Provenance of this abstract
Table 1. Field-by-field provenance. The Institute records which fields are extracted from a source and which are its own reconstruction, so that a reader can tell the two apart without leaving the page.
| Field | Provenance | Note |
|---|---|---|
| Design, phase, duration, primary endpoint | Extracted | Reproduced from the published report or the registry record. |
| Randomised participants | Not held | Not recorded by the Institute. The field is left empty rather than estimated. |
| Principal result | Extracted | Reproduced as published, with the confidence interval where the Institute holds it. |
| Centres, countries and baseline characteristics | Reconstructed | Derived by the Institute from the design class and the randomised total. Presented in §2 as an illustrative operational profile and marked as such. These figures are not published characteristics of this trial. |
| Certainty assessment | Institute judgement | The Institute’s own domain-by-domain assessment, with reasoning recorded against each domain in §4. |
| Registry identifier | Not held | The Institute does not reproduce a registry identifier it has not verified and never constructs one. Documents are referenced by the Institute’s own identifier. |