Metabolic clinical trials often involve patients with complex health profiles and comorbidities, which may have an impact on their quality of life. For instance, patients suffering from obesity may also have a range of cardiovascular complications and severe functional impairment. Another example is NASH/MASH patients, whose quality of life can be adversely affected, with NASH being associated with a mental and physical quality of life burden that worsens as the disease progresses.

Metabolic diseases clinical research lacks focus on these conditions, which require significant effort to be made in measuring patients’ symptoms, feelings, and overall quality of life. For example, NASH-CHECK, the only PRO questionnaire specific to the disease, is mentioned in just 0.6% of MASH protocols. Integrating PROs into MASH studies is crucial as this condition significantly affects patients’ daily activities, work, and mobility.