Introduction: Early identification of responders to weight loss (WL) medications is important to allow discontinuation in those unlikely to achieve WL targets. This subgroup analysis of SCALE Obesity and Prediabetes and SCALE Diabetes trials reports key outcomes in adults on liraglutide achieving ≥5% WL at Week (W) 16 (early responders; ER), compared to those who did not (early non-responders; ENR).
Methods: 2910 adults were randomised to liraglutide 3.0 mg as adjunct to diet & exercise: 2487 without T2D (BMI ≥30 or 27–29.9 kg/m2 + ≥1 comorbidity; 45 years; 21% male; BMI 38 kg/m2; 61% with prediabetes), and 423 with T2D (BMI ≥27 kg/m2; 55 years; 52% male; BMI 37 kg/m2). Mean and categorical WL were estimated by ANCOVA or logistic regression model, respectively. Efficacy data are LS means or estimated proportions for W56 completers; safety data are observed proportions.
Results: 67.5% of W16 completers without T2D were ER; at W56, mean WL was 11.5% and proportions with ≥5%, >10% and >15% WL were 88.2%, 54.8% and 24.2%, respectively. 50.4% of W16 completers with T2D were ER; at W56, mean WL was 9.3% and proportions with ≥5%, >10% and >15% WL were 80.1%, 44.6% and 11.6%, respectively. Pooled across trials, 93.4% of ENR failed to achieve ≥10% WL at W56. Greater improvements in CV risk factors were seen in ER than ENR, consistent with greater WL. Systolic blood pressure changes were greater in ER than ENR for participants with T2D (-5.5 vs. -2.3 mmHg, respectively) and without T2D (-3.8 vs. -1.3 mmHg, respectively). The safety profile was generally comparable between subgroups. In participants without T2D, rates of hepatobiliary disorders appeared higher in ER than ENR.
Conclusion: ER to liraglutide 3.0 mg achieved mean WL at W56 between 9.3% and 11.5%, whereas ENR were unlikely to achieve ≥10% WL at W56.