STEP — Semaglutide Treatment Effect in People with obesity
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.
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.
Sponsor class: Manufacturer-sponsored. First record: 2018.
Records in this programme
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-1 | Semaglutide | Phase 3 | Reported | Randomised, double-blind, placebo-controlled | 1,961 | 2021 | High |
| STEP-2 | Semaglutide | Phase 3 | Reported | Randomised, double-blind, placebo-controlled | 1,210 | 2021 | High |
| STEP-3 | Semaglutide | Phase 3 | Reported | Randomised, double-blind, placebo-controlled | 611 | 2021 | High |
| STEP-4 | Semaglutide | Phase 3 | Reported | Randomised withdrawal | 803 | 2021 | High |
| STEP-5 | Semaglutide | Phase 3 | Reported | Randomised, double-blind, placebo-controlled | 304 | 2022 | High |
| STEP-8 | Semaglutide | Phase 3 | Reported | Randomised, double-blind, active-controlled | 338 | 2022 | High |
| STEP-HFpEF | Semaglutide | Phase 3 | Reported | Randomised, double-blind, placebo-controlled | 529 | 2023 | Moderate |
| STEP-HFpEF-DM | Semaglutide | Phase 3 | Reported | Randomised, double-blind, placebo-controlled | 616 | 2024 | Moderate |
| STEP-TEENS | Semaglutide | Phase 3 | Reported | Randomised, double-blind, placebo-controlled | 201 | 2022 | Moderate |
| STEP-1-ADHERENCEprogramme record | Semaglutide | Phase 3 | Reported | Observational | — | 2021 | Very low |
| STEP-1-BIOMARKERprogramme record | Semaglutide | Phase 3 | Reported | Randomised, double-blind, placebo-controlled | — | 2021 | Very low |
| STEP-1-ELDERLYprogramme record | Semaglutide | Phase 3 | Reported | Randomised, double-blind, placebo-controlled | — | 2021 | Very low |
| STEP-1-OLEprogramme record | Semaglutide | Phase 3 | Reported | Single-arm open-label | — | 2021 | Very low |
| STEP-2-DDIprogramme record | Semaglutide | Phase 1 | Reported | Randomised crossover | — | 2021 | Very low |
| STEP-2-HEPATIC-IMPprogramme record | Semaglutide | Phase 1 | Reported | Phase 1 ascending dose | — | 2021 | Very low |
| STEP-2-PKprogramme record | Semaglutide | Phase 1 | Reported | Phase 1 ascending dose | — | 2021 | Very low |
| STEP-2-RENAL-IMPprogramme record | Semaglutide | Phase 1 | Reported | Phase 1 ascending dose | — | 2021 | Very low |
| STEP-3-ADHERENCEprogramme record | Semaglutide | Phase 3 | Reported | Observational | — | 2021 | Very low |
| STEP-3-BIOMARKERprogramme record | Semaglutide | Phase 3 | Reported | Randomised, double-blind, placebo-controlled | — | 2021 | Very low |
| STEP-3-ELDERLYprogramme record | Semaglutide | Phase 3 | Reported | Randomised, double-blind, placebo-controlled | — | 2021 | Very low |
| STEP-3-OLEprogramme record | Semaglutide | Phase 3 | Reported | Single-arm open-label | — | 2021 | Very low |
| STEP-4-DDIprogramme record | Semaglutide | Phase 1 | Reported | Randomised crossover | — | 2021 | Very low |
| STEP-4-HEPATIC-IMPprogramme record | Semaglutide | Phase 1 | Reported | Phase 1 ascending dose | — | 2021 | Very low |
| STEP-4-PKprogramme record | Semaglutide | Phase 1 | Reported | Phase 1 ascending dose | — | 2021 | Very low |
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