Novo Semaglutide, aka Ozempic, has added another feather to the cap besides reducing body weight. Ozempic has been shown to reduce the progression of chronic kidney disease (CKD). The FLOW trial has shown that administration of Semaglutide (1.0 mg) reduces the risk of kidney disease-related problems in patients suffering from type 2 diabetes. This reduction is 24 %, although the results are slightly below investors’ expectations.
Novo’s head of development, Martin Holst Lange, said, “Positive results from FLOW showed that Ozempic becomes the first Glucagon-like peptide-1(GLP-1) treatment option for people with type 2 diabetes and CKD”.
Novo started FLOW (NCT03819153) study in 2019. This study involved 3533 patients with type 2 diabetes having moderate to severe kidney problems. Besides receiving standard care, patients were administered mg of Semaglutide. FLOW was a randomized, double-masked, parallel-group, placebo-controlled, superiority trial that enrolled patients from 28 countries with 400 investigator sites. The trial’s completion date was August 2024, but it was halted prematurely due to the efficacy of early results. The Independent data monitoring committee recommended the efficacy of the results and asked to stop the FLOW trial. These approbatory results from interregnum analysis have met the pre-specified criteria. As assessed by an independent data monitoring committee. The trial included patients with estimated glomerular filtration rate (eGFR) of ≥50 and ≤75mL/min/1.73 m2 and Urinary albumin creatinine ratio (UACR) >300 and <5000 mg/g or eGFR ≥25 and <50 mL/min/1.73 m2 and UACR >100 and <5000 mg/g. The trial evaluated the primary endpoint, CKD progression, and the secondary endpoint included both CKD and cardiovascular components.
In the primary endpoints, five components were included, which are as follows (Campbell, 2024):
- Onset of persistent 50% or more significant reduction in eGFR compared to baseline.
- Onset of persistent eGFR of less than 15 mL/min/1.73 m2.
- Initiation of CKD replacement therapy, which included dialysis or kidney transplantation.
- Death from kidney disease
- Death from kidney-related cardiovascular disease.
Secondary endpoints incorporated changes in eGFR, irreparable/adverse cardiac events, for instance, non-fatal myocardial infarction, non-fatal stroke, and death related to cardiac vascular event or disease.
FLOW results successfully met primary and secondary endpoints. As mentioned above, patients suffering from T2 diabetes showed a 24 % reduction in death related to kidney and cardiac events. Given the success of the FLOW trail results, Novo is planning to file regulatory approvals for the Ozempic labels in both the USA and Europe in 2024. They also plan to present detailed clinical trial results at a scientific conference.
Approximately 40% of diabetic people suffer from CKD. The positive result of Semaglutide demonstrated potential for treating both diabetes and CKD. However, Novo’s success led to the tumbling of the shares of dialysis companies like DaVita and Fresenius Medical. The dialysis market sustains itself on an ever-increasing epidemic of obesity and diabetes—a major contributing factor to kidney disease.
It seems that GLP-1s have tremendous potential to treat health problems other than diabetes and obesity. This potential discovery has impacted the shares of company providers of services like bariatric surgery, food firms, and glucose monitoring devices.
Novo’s powerful weight loss drugs, Wegovy and Ozempic, share the same active ingredient, a GLP-1 agonist. Nevertheless, Novo is not the only company testing GLP-1 drugs for weight loss, diabetes, and renal benefits. Rival Eli Lilly is also conducting a clinical trial for the drug Trizeptide to evaluate its efficacy in treating CKD in obese patients with or without T2 diabetes (Jacobsen, 2024).
Reference:
- Campbell, P. (2024, March 5). Semaglutide 1.0 mg (Ozempic) Reduced Kidney Events 24% in FLOW Trial
- Jacobsen, S. Fick, M. (2024, March 5). Novo kidney trial finds Ozempic cuts cardiac deaths in diabetics.
