On October 11, the phenomenon-level drug semaglutide, which has been popular around the world in the name of "weight loss shot", made new progress: Novo Nordisk announced the early termination of its GLP-1 drug semaglutide for the treatment of patients with renal function. A phase 3 clinical FLOW trial in patients with type 2 diabetes and chronic kidney disease. In order to protect the integrity of the trial, the current specific trial results are still blinded to Novo Nordisk. It is expected that the FLOW results will be officially announced in the first half of 2024.

（图片来自 诺和诺德官网）

Semaglutide belongs to the GLP-1 receptor agonist (GLP-1RA) class of antidiabetic drugs. GLP-1 is an incretin that promotes insulin secretion in a glucose concentration-dependent manner, inhibits glucagon secretion, lowers blood sugar, and delays gastric emptying to suppress appetite.

About FLOW

The FLOW trial is a randomized, double-blind, placebo-controlled phase III clinical trial (registration number: NCT03819153).It compares the anti-diabetic preparation semaglutide injection 1.0 mg with placebo. The trial was launched in 2019. It was conducted in 28 countries and a total of 3534 patients were enrolled.

The primary objective of the trial is to compare the effectiveness of semaglutide in preventing progression of renal impairment and reducing renal and cardiovascular death, a composite primary endpoint of five, in patients with type 2 diabetes and chronic kidney disease (CKD). risk:

Compared to the baseline,

1）eGFR1 continues to decrease by ≥50%

2）ustained eGFR1<15mL/min/1.73m²

3）Start dialysis or kidney transplant

4）Death from kidney disease

5）Death from cardiovascular disease

Why do clinical trials need to be stopped when predetermined standards are reached?

Because clinical trials need to maintain clinical equipoise，That is to say, the experimenter needs to keep the possible benefits or risks of the subjects roughly equal in the random grouping.For clinical trials involving patients, it is also important to ensure that patients receive appropriate treatment.

In order to maximize the benefits and reduce risks for trial participants, most clinical trials will entrust an independent data monitoring committee to conduct real-time analysis of the trial.The trial can be terminated early when the committee finds that the planned interim analysis achieves the expected efficacy difference, such as the intervention program in the experimental group being significantly better than the control group.

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