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Key opinion leaders on GLP-1 receptor agonist clinical trial design

There are more than 50 glucagon-like peptide-1 receptor agonists (GLP-1RAs) in clinical development for Type 2 diabetes, obesity, or both.

Clinical trials on the efficacy and safety of these medicines and combination therapies involving them are ongoing, including cardiovascular outcome trials to prove further safety against cardiovascular events.

Speaking to leading data and analytics company GlobalData, several key opinion leaders (KOLs) expressed the need to implement some changes in the clinical trial design of GLP-1RA trials and obesity trials.

The primary endpoints in Type 2 diabetes and obesity GLP-1 receptor agonist trials are usually glycated haemoglobin (HbA1c) levels and changes in body mass index after the treatment period.

However, KOLs highlight the need for additional measurements and endpoints to better assess the patient’s health status, especially in the case of obesity: “It’s great to look at weight and A1c, but there’s not much data on activity, on physical function. You can get massive weight loss, and they say, ‘Oh, it’s better body composition,’ but I’m not completely convinced by that because when you lose weight, you tend to lose some lean mass.

“People with diabetes get accelerated ageing, and we don’t know what happens to your physical activity levels and what happens to your physical function with some of these drugs because it’s not really included as an endpoint.”

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Losing muscle mass is not ideal for someone trying to improve their physical condition and health, which is why experts highlight the need to identify what is “being lost” during the weight loss by GLP-1RA treatment.

Although these concerns are valid, it is important to point out that with any type of weight loss method, natural or pharmacological, some muscle-wasting effects can be observed, and it is hard to lose only fat mass.

According to a high-prescribers survey conducted by GlobalData, a good implementation in obesity clinical trial design could be to use methods such as bioelectrical impedance analysis and DEXA scanning, to better assess fat loss and body composition in trial subjects.

Another issue is patient representation in GLP-1RA clinical trials.

Representing the real-world population in clinical trials is one of the most important factors in clinical studies.

Race, gender, age, and status need to be taken into account when selecting patients, to make sure that the results of the study can be applied to all patients who are going to be prescribed the drug in the real world.

A KOL mentioned: “I think it’s important to make sure that we are very inclusive in the people that we include into these studies. So, for example, there are not so many studies in people aged under 50. If you look at the people that are included, they tend to be in their 60s and 70s, and, you know, that’s great for sort of getting the risk outcomes, but in reality a lot of people that we treat in the clinic are younger now. I think there’s underrepresentation of women.

“And a lot of women with Type 2 diabetes who are obese are of childbearing potential. We don’t have good data in that area. I think they tend to under-represent different minority groups. So if you’re very old, very young, and from a sort of underserved community, you’re not well-represented in the clinical trials. So we need to do that.”

Clinical trials are the main way to prove the efficacy and safety of a medicine, and thus their design and methodology need to be chosen to ensure the highest accuracy of what will happen in the real world, after approval.

Clinical trials need to provide strong evidence of the benefit of a medicine, in this case GLP-1RAs, over the alternatives.

Since GLP-1RAs are a relatively new class of drugs, many people are still waiting for longer-term studies and more information and accuracy on their effects on the body, and hopefully by implementing some changes in clinical trial design, patients and physicians may feel more reassured about the drugs’ benefits and clear their doubts.

Finally, implementation of these changes might help reach a greater patient population who could benefit from these medicines.