Outcome trial — Semaglutide 1.0 mg (Ozempic)
FLOW: trial summary, limitations and UK relevance
Semaglutide 1.0 mg weekly reduced the primary composite kidney outcome versus placebo in adults with type 2 diabetes and CKD, establishing GLP-1 receptor agonist benefit in a kidney-outcome trial. The trial was stopped early at the planned interim analysis for efficacy. Reported hazard ratio: ~0.76 (95% CI ~0.66–0.88) in the primary NEJM publication.
Key findings
Semaglutide 1.0 mg weekly reduced the primary composite kidney outcome versus placebo in adults with type 2 diabetes and CKD, establishing GLP-1 receptor agonist benefit in a kidney-outcome trial. The trial was stopped early at the planned interim analysis for efficacy. Reported hazard ratio: ~0.76 (95% CI ~0.66–0.88) in the primary NEJM publication.
Safety summary
Safety profile broadly consistent with the wider semaglutide programme. No new major safety concerns reported in the primary publication.
Limitations
- Stopped early — late safety signals could be under-characterised.
- Population limited to T2D + CKD; does not directly establish kidney benefit in non-diabetic CKD.
UK relevance
Provides UK clinically relevant kidney-outcome evidence for semaglutide 1.0 mg in T2D + CKD populations, informing NHS diabetes-renal pathways.
- Does not establish kidney benefit at the higher 2.4 mg obesity dose specifically.
- Does not establish kidney benefit in non-diabetic CKD populations.
Frequently asked questions
What did FLOW study?
FLOW was an outcome trial of once-weekly semaglutide 1.0 mg (Ozempic) versus placebo in approximately 3,500 adults with type 2 diabetes and chronic kidney disease. The primary endpoint was a composite kidney outcome: persistent ≥50% eGFR reduction, kidney failure, or kidney or cardiovascular death. The trial was stopped early at its planned interim analysis for efficacy.
What did FLOW find?
Semaglutide 1.0 mg reduced the primary composite kidney outcome versus placebo, with a reported hazard ratio of approximately 0.76 (95% CI ~0.66–0.88) in the primary NEJM 2024 publication (Perkovic et al.) — the first GLP-1 receptor agonist kidney-outcome trial to show this benefit.
Does FLOW apply to the obesity dose or to non-diabetic CKD?
No. FLOW studied semaglutide 1.0 mg in adults with type 2 diabetes and CKD. It does not establish kidney benefit specifically at the higher 2.4 mg obesity dose, nor in non-diabetic CKD populations. Stopping early for efficacy can also under-characterise later safety signals.
Related peptide profiles
Related trials
No published trials yet linked to this page. Source verification required.
Related conditions
Related mechanisms
Related safety signals
Sources are tagged by class. Regulatory documents, peer-reviewed publications and trial registry records are preferred. Manufacturer disclosures and conference material are accepted where peer-reviewed publication is not yet available; preprints are flagged.
- Peer-reviewed publicationPerkovic V et al., Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes (FLOW). NEJM 2024.
- Trial registry recordClinicalTrials.gov NCT03819153