Phase 3 · Semaglutide

FLOW trial results

Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease

Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death (Participants), From Week 0 up to Week 234. Semaglutide: 331; Placebo: 410.

Participants
3,533
Status
completed
Completed
2024-01-09
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT03819153), updated at source Mar 20, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What FLOW measured first

Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV DeathParticipants · From Week 0 up to Week 234 · count of participants
Semaglutiden=1,767Placebon=1,766
331410
Side effects by arm

Side effects in FLOW

Percent of participants affected, From Week 0 up to Week 238. The most common events the registry lists.

EventSemaglutidePlacebo
Any serious event49.6%53.8%
Diabetic retinopathy19.2%18.4%
COVID-1912.5%13.9%
Secondary outcomes

What else it measured

Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)(mL/min/1.73 m^2)/year · From Week 0 up to Week 234 · mean
Semaglutiden=1,767Placebon=1,766
-2.19(0.1)-3.36(0.1)
Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI)Participants · From Week 0 up to Week 234 · count of participants
Semaglutiden=1,767Placebon=1,766
165213
Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2Participants · From Week 0 up to Week 234 · count of participants
Semaglutiden=1,767Placebon=1,766
92110
Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement TherapyParticipants · From Week 0 up to Week 234 · count of participants
Semaglutiden=1,767Placebon=1,766
87100
Number of Participants From Time of Randomization to Occurrence of Renal DeathParticipants · From Week 0 up to Week 234 · count of participants
Semaglutiden=1,767Placebon=1,766
55
Number of Participants From Time of Randomization to Occurrence of CV DeathParticipants · From Week 0 up to Week 234 · count of participants
Semaglutiden=1,767Placebon=1,766
123169
Annual Rate of Change in eGFR (Chronic Kidney Disease CKD-EPI) (Chronic eGFR Slope)mL/min/1.73 m^2 · Week 12, Week 234 · mean
Semaglutiden=1,735Placebon=1,736
-2.36(0.1)-3.30(0.1)
Change From Baseline in eGFR (CKD-EPI) at Week 12mL/min/1.73m^2 · Baseline (Week 0), Week 12 · mean
Semaglutiden=1,665Placebon=1,663
-1.07(8.16)-1.07(7.73)
Change From Baseline in eGFR (Cystatin C CKD-EPI) at Week 104mL/min/1.73m^2 · Baseline (Week 0), Week 104 · mean
Semaglutiden=1,425Placebon=1,391
-2.1(11.4)-5.4(9.7)
Change From Baseline in Urinary Albumin-to-creatinine Ratio (UACR) at Week 104: Ratio to BaselineRatio · Baseline (Week 0), Week 104 · geometric mean
Semaglutiden=1,454Placebon=1,423
0.60(224.09)0.89(211.70)
Number of Participants From Time of Randomization to Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Acute Myocardial Infarction (Non Fatal); Non-fatal Stroke; and CV DeathParticipants · From Week 0 up to Week 234 · count of participants
Semaglutiden=1,767Placebon=1,766
212254
Number of Participants From Time of Randomization to Time to Occurrence of All-cause DeathParticipants · From Week 0 up to Week 234 · count of participants
Semaglutiden=1,767Placebon=1,766
227279
The trial

How FLOW was run

The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer.

  • Semaglutide: Participants are to receive semglutide for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.
  • Placebo: Participants are to receive placebo (semglutide) for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.
Who could join the trial

Inclusion Criteria: * Male or female, age above or equal to 18 years at the time of signing informed consent. Japan: Male or female, age above or equal to 20 years at the time of signing informed consent * Diagnosed with type 2 diabetes mellitus * HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol) * Renal impairment defined either by: 1. serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m\^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or 2. serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m\^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g * Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening Exclusion Criteria: * Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations * Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to screening * Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening * Presently classified as being in New York Heart Association (NYHA) Class IV heart failure * Planned coronary, carotid or peripheral artery revascularisation * Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Published papers

Papers from FLOW

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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