FLOW (NN9535-4321) Semaglutide renal outcomes trial
FLOW- Effect of semaglutide versus placebo on the progression of renal impairment in subjects with type 2 diabetes and chronic kidney disease
Duration of Study in the UK
5 years, 2 months, days
Many patients have both chronic kidney disease (CKD) and diabetes. For many the kidney damage and/or reduced kidney function is caused by longstanding and poorly controlled diabetes. There is a medical need to improve the treatment of CKD in patients with Type 2 Diabetes.
The purpose of the FLOW study (NN9535-4321) is to determine if once weekly injection of semaglutide, a Glucagon like peptide 1 receptor agonist (GLP1-RA), delays progression of kidney disease and lowers the risk of death related to the kidneys or the cardiovascular system in patients with Type 2 Diabetes and CKD.
Eligible participants will be randomly assigned to receive either once-weekly injection of semaglutide or placebo, both in addition to standard of care treatment. All treatments will be administered once weekly by subcutaneous (under the skin) injection. The study is blinded, meaning that neither the participant nor the study doctor will know whether the participant is receiving the active or placebo (dummy) medication.
The study is event driven meaning it will end when a pre-defined number of cardio-renal (heart and kidney) endpoints is reached. The trial duration for each subject is expected to be between 3 years up to 5 years and a maximum of 28 planned clinic visits (for the first participant).
The study plans to include 3,160 participants across 28 countries, including 100 participants from the UK.
West Midlands - Edgbaston Research Ethics Committee
Date of REC Opinion
2 Apr 2019
Further Information Favourable Opinion