Development programme
STEP — Semaglutide Treatment Effect in People with obesity — page 2
The phase 3 programme supporting the 2.4 mg once-weekly presentation of semaglutide for chronic weight management. The trials share a titration schedule, a 68-week primary analysis timepoint and a common set of co-primary and confirmatory secondary endpoints, which is the reason the Institute treats the programme as poolable.
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Records in this programme
40 documents · page 2 of 2
Table 1. Trial records on this page. The table sorts on any column and filters on the controls above; both operate on the records shown on this page only.
| Record | Compound | Phase | Status | Design | Randomised | Year | Certainty |
|---|---|---|---|---|---|---|---|
| STEP-4-RENAL-IMPprogramme record | Semaglutide | Phase 1 | Reported | Phase 1 ascending dose | — | 2021 | Very low |
| STEP-5-DDIprogramme record | Semaglutide | Phase 1 | Reported | Randomised crossover | — | 2022 | Very low |
| STEP-5-HEPATIC-IMPprogramme record | Semaglutide | Phase 1 | Reported | Phase 1 ascending dose | — | 2022 | Very low |
| STEP-5-PKprogramme record | Semaglutide | Phase 1 | Reported | Phase 1 ascending dose | — | 2022 | Very low |
| STEP-5-RENAL-IMPprogramme record | Semaglutide | Phase 1 | Reported | Phase 1 ascending dose | — | 2022 | Very low |
| STEP-8-BIOMARKERprogramme record | Semaglutide | Phase 3 | Reported | Randomised, double-blind, placebo-controlled | — | 2022 | Very low |
| STEP-8-DDIprogramme record | Semaglutide | Phase 1 | Reported | Randomised crossover | — | 2022 | Very low |
| STEP-8-HEPATIC-IMPprogramme record | Semaglutide | Phase 1 | Reported | Phase 1 ascending dose | — | 2022 | Very low |
| STEP-8-PKprogramme record | Semaglutide | Phase 1 | Reported | Phase 1 ascending dose | — | 2022 | Very low |
| STEP-8-RENAL-IMPprogramme record | Semaglutide | Phase 1 | Reported | Phase 1 ascending dose | — | 2022 | Very low |
| STEP-HFpEF-DDIprogramme record | Semaglutide | Phase 1 | Reported | Randomised crossover | — | 2023 | Very low |
| STEP-HFpEF-DM-BODY-COMPprogramme record | Semaglutide | Phase 3 | Reported | Randomised, double-blind, placebo-controlled | — | 2024 | Very low |
| STEP-HFpEF-HEPATIC-IMPprogramme record | Semaglutide | Phase 1 | Reported | Phase 1 ascending dose | — | 2023 | Very low |
| STEP-TEENS-DDIprogramme record | Semaglutide | Phase 1 | Reported | Randomised crossover | — | 2022 | Very low |
| STEP-TEENS-HEPATIC-IMPprogramme record | Semaglutide | Phase 1 | Reported | Phase 1 ascending dose | — | 2022 | Very low |
| STEP-TEENS-PKprogramme record | Semaglutide | Phase 1 | Reported | Phase 1 ascending dose | — | 2022 | Very low |
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