GLP-1R agonists clinical trial design needs to be improved for reassuring drugs benefits : GlobalData – ET HealthWorld | Pharma

New Delhi: The clinical trial methodology used to test the efficacy of GLP-1R drugs needs improvement to assure their effectiveness. benefits For patients, states global dataA data and analytics company.

GLP-1R (glucagon-like peptide-1) receptor agonist drugs are used in the treatment of: diabetes type 2 And obesity,

The efficacy of these drugs has been proven to be excellent in clinical trials and in the real world, according to GlobalData. However, some patients and physicians are still a bit skeptical about some of the effects and adverse events associated with this drug class.

Commenting on the stand, Costanza Alciati, a senior pharma analyst at GlobalData, said, “The main endpoints in the GLP-1R agonist trials are reduction in HbA1c levels in the case of type 2 diabetes studies, and reduction in body weight, which is It is measured with.” body mass index (bmi), in the case of obesity studies. The problem with measuring BMI to determine the amount of weight loss in a patient is that it does not provide any information about how much of the fat mass is being lost versus lean mass or muscle mass. For this reason, physicians may be more skeptical of prescribing GLP-1R agonists because studies do not fully characterize the nature of weight loss.

According to a high-prescriber survey conducted by GlobalData, a good implementation in obesity clinical trial design Methods such as bioelectrical impedance analysis (BIA) and DEXA scanning can be used to better assess fat loss and body composition in test subjects.

Key opinion leaders (KOLs) have also highlighted the need for more data on physical function or activity. With rapid aging, which is a result of diabetes, one’s physical condition deteriorates; Therefore, it is important to assess the physical activity levels of diabetic patients in clinical trials.

  • Published on May 1, 2024 at 01:15 PM IST

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