Clinical Data Mega-Collection of Obesity and Obesity-Related Trials: Primary Inclusion Criteria from All Studies and Highlights of Clinical Efficacy Analysis of GLP-1 Drugs.

Obesity is heterogeneous and considered a chronic epidemic with significant un-met needs for management, treatment, and prevention. In this study, we used LizAI's software TAITAN (alpha version) for the mega-collection and analysis of clinical data from 10,407 trials addressing obesity and obesity-related diseases and their associated publications, mainly on PubMed. We report an intensive growth of clinical trials until the end of 2024 and highlight the use of the body mass index (BMI) as a critical criterion in clinical participant selection despite its limitations. The significant disparities in races, regions, and the sites of trials across all studies have not been addressed, posing the possibility of research in the far future on the applications of precision medicine in weight management. In the latter parts of this paper, we analyze and discuss the clinical efficacy, mainly focusing on the primary endpoints and benchmarks of the recently FDA-approved once-weekly injectable glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs, including semaglutide and tirzepatide. Both drugs have functioned comparably when considering the 5% weight loss FDA threshold. Tirzepatide outperforms semaglutide and impacts fewer participants as the weight loss level increases from 5 to 20% and has greater effects in different populations, especially in people with type 2 diabetes (T2D). We would, however, like to highlight that (i) the weight loss level should be dependent on the clinically relevant needs of patients, and faster and greater weight loss might not be a win, and (ii) the clinical benefits, safety, and quality of life of patients should be carefully assessed when the weight loss is significant in a short period. In our search, we found that the specificities and impacts of weight loss therapies on organs like the kidneys and heart, different muscle types, bones, and fat accumulation in different parts of body were not investigated or disclosed during the clinical study period and longer term monitoring. In light of scientific needs and remarkable public interest in weight loss, our report provides findings on the buzz around losing weight in clinical trials, and our TAITAN software continues to collect data in real time and enrich its knowledge for future updates.