GLP-1R agonists clinical trial design must be improved to ease concerns
The efficacy of these medicines in type 2 diabetes and obesity patients has been proven to be excellent in clinical trials and in the real world.
However, some patients and physicians are still skeptical about certain side effects and adverse events related to this drug class.
Therefore, data and analytics firm GlobalData argues that implementing some changes in the clinical trial design of GLP-1R agonists trials could lead to a better understanding of these medications.
According to GlobalData, there are currently over 50 clinical trials for type 2 diabetes or obesity treatment involving GLP-1R agonists.
Costanza Alciati, pharma analyst at GlobalData, said: “The main endpoints in GLP-1R agonist trials are HbA1c levels reduction, in the case of type 2 diabetes studies, and a reduction in body weight, measured with the body mass index (BMI), in the case of obesity studies.
“The problem with measuring the BMI to quantify the weight loss a patient is experiencing is that it gives no information about what share of fat mass is being lost vs. lean mass or muscle mass. For that reason, physicians may be more skeptical to prescribe a GLP-1R agonist as studies don’t fully characterize the nature of the weight lost.”
According to a high-prescribers study conducted by GlobalData, a good implementation in obesity clinical trial design could be to use methods such as bioelectrical impedance analysis (BIA) and DEXA scanning to better assess fat loss and body composition in trial subjects.
Key opinion leaders (KOLs) interviewed by the data organization have also highlighted the need for more data on physical function and activity.
With accelerated aging, which is a consequence of diabetes, someone’s physical condition worsens; therefore, it’s important to assess the physical activity levels of diabetes patients in clinical trials.
Alciati continues: “Another issue is patient representation. Representing the real-world population in clinical trials is one of the most important things in clinical studies. Race, gender, age, and status need to be considered when selecting patients. KOLs pointed out the fact that clinical study patients in GLP-1R agonists trials are usually in their 60s and 70s However, in practice, many patients are younger than that.”
In addition, there is an under-representation of women, women with child-bearing potential, and minority groups in these clinical trials.
Alciati concludes: “GLP-1R agonists can potentially help a huge number of patients. Hopefully, by implementing some changes in clinical trial design, patients and physicians will feel more reassured about the drugs’ benefits.”
