DANU-PH2B-OBESITY — structured trial abstract
DANU-PH2B-OBESITY — Danuglipron in obesity: randomised, double-blind, placebo-controlled
§1Structured abstract
§1.1Objective
To evaluate Danuglipron in 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 2b
- Randomised participants
- 605
- Duration of the primary analysis period
- 32 weeks
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Percentage change in body weight from baseline to week 32
§1.4Principal result
Dose-dependent weight reduction accompanied by discontinuation rates above 50 % in some arms; development in obesity was subsequently discontinued.
The Institute treats a discontinued programme as evidence. A tolerability profile that produces majority discontinuation is a result, not an absence of one.
§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 | Extracted | Reproduced as published. |
| 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. |