Introduction: The Therapeutic Goods Administration (TGA) prescribing information for liraglutide 3.0 mg defines the stopping rule for individuals achieving <5% body weight (BW) reduction after 12 weeks’ treatment on the 3.0 mg/day dose. The SCALE IBT study demonstrated the overall efficacy of liraglutide 3.0 mg for weight reduction as adjunct to IBT. The present analysis explored the effect of intervention in an early responders (ER) subgroup corresponding to liraglutide-treated individuals who lost ≥5% BW at week 16 and who would have been eligible to continue treatment in a real-world clinical setting.
Methods: The 56-week SCALE IBT trial randomised adults with obesity (BMI ≥30kg/m²) to liraglutide 3.0 mg or placebo as an adjunct to a Centers for Medicare & Medicaid Services-based programme of IBT, including prescribed exercise (escalating to 250 min/week) and diet (1200–1800 kcal/day). This exploratory post-hoc analysis assessed ER subgroup outcomes in liraglutide 3.0 mg-treated individuals after 56 weeks’ treatment.
Results: Mean characteristics at randomisation (n=142) for liraglutide 3.0 mg-treated individuals were: 45.4 years, 83.8% female, 109kg, BMI 39.3kg/m². At 16 weeks, 66.9% of these achieved ≥5% weight loss. At 56 weeks, mean weight reduction in this ER subgroup was 10.4%; 79.9% and 44.2% achieved weight loss ≥5% and ≥10%, respectively, and 88.4% were still on-drug. Improvements in cardiometabolic endpoints including waist circumference, blood pressure, lipids and HbA1c were observed. Adverse events (AEs) were similar across the ER subgroup and the overall trial population. The most frequent AEs were gastrointestinal events (74.7% in the ER subgroup versus 71.1% and 48.6% in the overall liraglutide and placebo groups).
Conclusion: Over two-thirds of individuals with obesity receiving liraglutide 3.0 mg as adjunct to IBT were eligible for long-term treatment according to the TGA prescribing information. Of these, the majority continued on therapy to 56 weeks, achieving clinically relevant weight loss.