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This study was designed to develop a model to characterize the relationship between semaglutide exposure levels and weight-loss trajectories following semaglutide treatment and evaluate how accurately this model-based method can predict individual 1-year weight-loss outcomes. The authors developed an exposure–response model to predict weight-loss trajectories using baseline characteristics, HbA1c, and pharmacokinetic data. Overall, the model adequately described the observed mean on-treatment weight-loss trajectories across treatment arms and the investigated exposure range. The authors concluded that an exposure–response model quantitatively describes the relationship between systemic semaglutide exposure and weight loss and predicts individual weight-loss trajectories for people with overweight or obesity receiving semaglutide doses up to 2.4 mg once weekly.
Predicting an individual's expected weight loss during semaglutide treatment would be valuable to enable clinically relevant guidance and monitoring of treatment targets. By using an exposure–response model, physicians could create a more individual approach to weight loss with treatment-matching expectations.
To determine the relationship between exposure and weight-loss trajectories for the glucagon-like peptide-1 analogue semaglutide for weight management.
MATERIALS AND METHODS
Data from one 52-week, phase 2, dose-ranging trial (once-daily subcutaneous semaglutide 0.05-0.4 mg) and two 68-week phase 3 trials (once-weekly subcutaneous semaglutide 2.4 mg) for weight management in people with overweight or obesity with or without type 2 diabetes were used to develop a population pharmacokinetic (PK) model describing semaglutide exposure. An exposure-response model describing weight change was then developed using baseline demographics, glycated haemoglobin and PK data during treatment. The ability of the exposure-response model to predict 1-year weight loss based on weight data collected at baseline and after up to 28 weeks of treatment, was assessed using three independent phase 3 trials.
Based on population PK, exposure levels over time consistently explained the weight-loss trajectories across trials and dosing regimens. The exposure-response model had high precision and limited bias for predicting body weight loss at 1 year in independent datasets, with increased precision when data from later time points were included in the prediction.
An exposure-response model has been established that quantitatively describes the relationship between systemic semaglutide exposure and weight loss and predicts weight-loss trajectories for people with overweight or obesity who are receiving semaglutide doses up to 2.4 mg once weekly.