The worldwide prevalence of obesity has doubled over the past three decades, contributing to a marked increase in type 2 diabetes mellitus. Obesity contributes to numerous comorbid conditions. Obese patients are at increased risk of developing many medical problems, including insulin resistance, type 2 diabetes mellitus, hypertension, dyslipidemia, cardiovascular disease, stroke, sleep apnoea, gall bladder disease, hyperuricemia, gout, osteoarthritis and even certain cancers.
Whereas drugs initially marketed for weight loss in obesity were relatively inefficacious or suffered from problematic safety profiles, the obesity market changed fundamentally with the advent of GLP-1 receptor agonists. These drugs, initially developed for type 2 diabetes, were shown to induce substantial weight loss also in people without diabetes. Recently, weight loss in obese people with established cardiovascular disease was shown to reduce mortality.
Whereas the proof-of-concept for a new drug under development can often already be picked up in a first in human trial where healthy volunteers already lose weight, more sophisticated methods are needed for mode of action trials. The following are available at Profil: