Docs Who Lift Semaglutide vs. Tirzepatide: Are We Closing the Gap?
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Jul 24, 2025 Sean Wharton, a physician and clinical trialist renowned for his work on obesity and the STEP-UP trial, shares fascinating insights on the advancements in weight loss treatments. He discusses the significance of the higher 7.2mg dose of semaglutide, trial design intricacies, and the promising future of dual and triple therapies. The conversation highlights the barriers to healthcare access, the role of intermittent fasting in weight management, and the importance of nutrition science, particularly in addressing biases that affect dietary guidelines.
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Dose Selection by Modeling
- The semaglutide dose of 2.4mg was chosen based on pharmacokinetic modeling rather than a traditional phase two weekly trial.
- This modeling allowed the leap from daily to weekly dosing without intermediate trials, speeding drug development.
Safety Basis of Triple Dose
- The higher dose 7.2mg semaglutide in STEP-UP trial was deemed safe based on pharmacokinetic data from oral semaglutide studies.
- Area under the curve modeling justified tripling the dose before clinical testing in humans.
Trial Design and Randomization
- The STEP-UP trial compared semaglutide 7.2mg to 2.4mg and placebo with a 5:1:1 randomization to study safety and efficacy.
- More patients were assigned to the higher dose to power both efficacy and safety assessments adequately.