The Therapeutic Goods Administration (TGA) approved Ozempic based on results from the FLOW phase 3b trial. This study looked at how weekly Ozempic injections affected kidney and heart health in adults with type 2 diabetes and chronic kidney disease (CKD).

The FLOW trial achieved its main goal with Ozempic 1 mg. When added to standard care, it significantly reduced the risk of kidney disease progression, kidney failure (end-stage kidney disease), and death from cardiovascular causes by 24% compared to a placebo. This translates to an absolute risk reduction of 4.9% over three years.

Outcomes

Outcome	Result
Glycaemic Management	Up to 80% of patients achieved HbA1c levels <7%
Weight Reduction	up to 6.5kg weight loss
CV Safety	26% RRR in MACE
Major Kidney Disease Events	24% RRR in major kidney disease events
All-cause Death	20% RRR in all-cause death

CV = cardiovascular
RRR = Relevant Risk Reduction
MACE = Major Adverse Cardiovascular Events

About FLOW

The FLOW trial began in 2019 and was a randomised, double-blind, placebo-controlled study. It compared semaglutide 1.0mg with a placebo, both given alongside standard care, to see how they affected the progression of kidney disease and the risk of death from kidney or heart-related causes in people with type 2 diabetes and CKD.

Trial Purpose	Population	CKD Definition	Enrolment		Countries		Investigator Sites
Effect of treatments on kidney outcomes, prevention of progression of kidney disease, risk of kidney and cardiovascular mortality	People with type 2 diabetes and CKD	eGFR ≥50 and ≤75mL/min UACR >300 and <5,000 mg/g or eGFR ≥25 and <50mL/min/ UACR >100 and <5,000 mg/g		3,533 people		28	around 400

Aims of FLOW

The FLOW trial aimed to show that chronic kidney disease (CKD) could be slowed and the risk of death from kidney or heart-related causes reduced. To measure this, researchers used a combined primary outcome that included:

• a persistent drop in eGFR of 50% or more
• a sustained eGFR below 15 mL/min/1.73 m²
• the need for dialysis or a kidney transplant
• death from kidney disease
• or death from cardiovascular causes.

Secondary outcomes included:

• the yearly change in eGFR
• major cardiovascular events (such as non-fatal heart attack, non-fatal stroke, or cardiovascular death)
• and death from any cause.

By Donna Itzstein, Pharmacist and Credentialled Diabetes Educator

References

Novo Nordisk Pty Ltd. (2025, August 20th). Email: Ozempic (semaglutide) new indication in adults withT2D and CKD.
Paola, S. (2025, August 20). New indication for Ozempic. Australian Journal of Pharmacy. Retrieved from https://ajp.com.au/news/new-indication-for-ozempic
European Renal Association Congress (ERA) in May 2024 and published in the New England Journal of Medicine (NEJM).3,14