Introduction & Objective: In the past years, many obesity drugs were approved by the FDA and withdrawn. Semaglutide and tirzepatide are dominating the obesity market. We analyzed published phase 2/3 clinical trials to evaluate their efficacy and safety.
Methods: We selected 17 randomized phase 2/3 trials. Participants had obesity, diabetes, or both. Outcomes were baseline - post treatment differences: efficacy [body wt (kg/%), fasting glucose (mg/dL), HbA1c (%)]; safety [nausea, diarrhea, vomiting, constipation]; also age, %women, %white, sample size, and duration, To estimate pooled differences, we used bootstrapping, a machine learning/AI methodology to resample a dataset, generating a sampling distribution for statistical calculations. We estimated means, 95%CI of the differences by performing 10,000 resamples.
Results: Table 1: Across the 17 trials, semaglutide and tirzepatide lowered body by 8.5 and 10.7 %; fasting glucose by 29.8 and 51.8 mg/dL; HbA1c by 1.1 and 1.8%, respectively.
Conclusion: Semaglutide and tirzepatide are comparable in their efficacy and safety profile. Tirzepatide is better at reducing fasting glucose. Dual agonism at GIP and GLP-1R may contribute to the weight control effects of tirzepatide. At the ADA conference, Biomed introduces NA-931, a new oral drug with triple agonism at GIP/ GLP-1 and IGF-1 as an alternative treatment with less AEs for those with obesity and diabetes.
Z.V. Tran: Employee; Biomed Industries, Inc.
