PRAM-OBESITY-PH2-OLE — design and population
Design, allocation, arms and the population enrolled.
Institute-constructed programme record. This document is not a report of a published trial. It is a record the Institute has constructed to represent an instalment, sub-study or extension of a real development programme, published in order to carry a methodological point that the parent trial report does not address. No effect estimate on this page is attributable to any publication, and its reference-list entry carries a programme-record label rather than a citation. The policy governing these records was settled through a public comment period.
§2Design and population
§2.1Design and allocation
- Design class
- Single-arm open-label study
- Masking
- None
- Arms
- 1
- Allocation
- Single arm; no randomisation
- Endpoint adjudication
- Not applicable to the primary endpoint of this design
- Data monitoring
- As specified in the protocol
§2.2Arms
Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.
| Arm | Allocated | Share | Description |
|---|---|---|---|
| Pramlintide | — | — | Open-label active treatment; no randomised comparator |
| The randomised total is not recorded by the Institute and arm-level figures are therefore not presented. | |||
§2.3Population
Indication. Obesity and overweight in adults
Excess adiposity sufficient to impair health, operationalised in the pivotal incretin programmes as a body-mass index of 30 kg/m² or above, or 27 kg/m² or above with at least one weight-related comorbidity.
Geographic footprint. Mexico.
§2.4Eligibility as the Institute reads it
- Included. Excess adiposity sufficient to impair health, operationalised in the pivotal incretin programmes as a body-mass index of 30 kg/m² or above, or 27 kg/m² or above with at least one weight-related comorbidity.
- Excluded. Participants for whom the intervention is contraindicated, including confirmed gastroparesis. Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.