The FDA's new guidelines have set clear standards for the efficacy of obesity treatment drugs. It is stipulated that after one year of use at the maintenance dose, compared with the placebo group, if the patient's weight is reduced by at least 5% and there is a statistically significant difference, the drug can be considered effective1. This provides a clear reference for the R & D and evaluation of new drugs.

In terms of trial scale, the guidelines require that the safety database should include at least 3,000 subjects, of which at least 1,500 receive placebo treatment, and the research period should be at least one year1. This is to ensure that there is sufficient statistical power to detect adverse events and ensure the safety of drug use.

The guidelines also emphasize the need for additional monitoring and safety assessments for different types of drug development projects1. For example, if a cardiac risk signal is found during the development process, a cardiovascular outcome trial may be required.

The release of these guidelines has a significant impact on the R & D of obesity treatment drugs. It not only raises the bar for the efficacy and safety of new drugs but also provides a clear direction for pharmaceutical companies and researchers, promoting the healthy development of the obesity treatment drug market.