Objective: The purpose of this study was to investigate whether pre-treatment subject characteristics and weight change during the first weeks of a low-calorie diet (LCD) can predict weight loss outcomes at the end of a controlled 8-week weight loss period in overweight and obese adults. Subjects: A total of 932 overweight and obese subjects of both genders were included at eight European centers, and underwent an 8-week LCD period. Results: The weight loss at week 8 was positively correlated with initial body weight (Spearman's r ¼ 0.62), height (r ¼ 0.43), body mass index (r ¼ 0.43), waist (r ¼ 0.48) and hip circumference (r ¼ 0.33), sagittal diameter (r ¼ 0.45), fat mass (r ¼ 0.35) and fat-free mass (r ¼ 0.52), and gender (r ¼ À0.36) (all Po0.01). In the multivariate regression model, adjusted for center, only initial body weight, early weight loss (week 1) and weight loss at week 3 were significant predictors of weight loss outcome at week 8: weight loss (kg) at week 8 ¼ 0.09 þ 0.046 Â baseline body weight (kg)À0.311 Â weight loss (kg) at week 1 þ 1.284 Â weight loss (kg) at week 3 (R 2 ¼ 68%, Po0.0001). A weight loss of X2.6 kg at week 1 during the LCD period was identified as the optimal cut-off predictor for at least 10 kg weight loss at week 8. Conclusions: This study suggests that initial body weight, early weight loss (week 1) and weight loss at week 3 are predictors of final weight loss during an 8-week LCD, and may be used as early biomarkers of subsequent responses to an LCD diet.