Type 2 diabetes can be considered as a complex and evolving disease. Starting from a prediabetic state, currently diagnosed as a chronic hyperglycemic condition, the disease can lead not only to serious macrovascular complications such as myocardial infarction or cerebrovascular events, but also to microvascular complications such as retinopathy, nephropathy, and diabetic foot ulcers.

Currently, a total of 57 million people suffer from Type 2 diabetes in North America, Europe, and Japan, of which only 49% have been diagnosed. In the US, 35% of the adult population (79 million people) are estimated to have prediabetes (elevated fasting glucose or elevated levels of glycated hemoglobin, HbA1c).

Faced with the scale of the Type 2 diabetes epidemic, the prevention and treatment of this disease and its associated micro- and macrovascular complications represents a major public health issue, as declared by both academic societies (IAS, ADA, EASD) and international health organizations (WHO, FDA, EMEA).

Cardiometabolic disorders such as diabetes, dyslipidemia, obesity, and hypertension are today considered to be intimately linked, and can lead to serious and even fatal complications such as atherosclerosis, myocardial infarction, and stroke. Indeed, cardiovascular disease is 2-4 times higher in diabetics, and diabetes is the leading cause of new cases of kidney failure and blindness, and of non-traumatic lower limb amputation.

In addition, obesity, prediabetes, and diabetes are often associated with chronic liver diseases resulting from the accumulation of fat in hepatic cells (steatosis). The prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) can reach 70% in diabetic patients. A sub-population of NAFLD patients suffers from Non-Alcoholic Steato- Hepatitis (NASH), that can result in severe fibrosis, cirrhosis, and liver cancer. There is currently no approved drug for the treatment of NAFLD/NASH.

Today, the therapeutic management of Type 2 diabetic patients must consider dyslipidemia, prediabetes, and diabetes as distinct stages of the same chronic and evolving disease. The early stages of the disease are characterized by asymptomatic organ dysfunction, while the later stages involve organs such as the pancreas (resulting in hyperglycemia), vasculature (atherosclerosis), kidneys (diabetic nephropathy), eyes (retinopathy), and liver (NAFLD/NASH).

Current therapeutic options, whilst having beneficial effects, are not capable of significantly reducing diabetes-associated morbidity and mortality. There is thus a great need for new therapeutic solutions that target the early pathological process whilst taking into account the multi-factorial nature of cardiometabolic disease.