Liraglutide + intensive behavioural therapy encourages weight loss in non-diabetic, obese patients
In the primary care setting, adding liraglutide to intensive behavioural therapy (IBT) conferred greater weight loss than IBT alone among individuals with obesity, results from the phase IIIB SCALE* IBT study showed.
Non-diabetic adults with obesity (BMI ≥30 kg/m2; stable body weight [≤5 kg change in the past 90 days]) from 17 centres in the US** were randomized to receive either subcutaneous liraglutide (3.0 mg QD***; n=142, mean age 45.4 years, 16.2 percent male) or placebo (n=140, mean age 49.0 years, 17.1 percent male) adjunct to IBT for 56 weeks. IBT consisted of 23 counselling sessions of about 15 minutes each for 56 weeks (QW in month 1, Q2W in months 2–6, and monthly in months 7–13), as well as specific intensive diet (based on weight at baseline, eg, 1,800 kcal/day for those weighing >136 kg) and physical activity (gradual increase to 250 minutes/week) guidelines.
At week 56, individuals on liraglutide-IBT had significantly greater weight loss from baseline than those on placebo-IBT (mean weight loss 7.5 percent vs 4.0 percent; estimated treatment difference -3.4 percent, 95 percent confidence interval, -5.3 to -1.6 percent; p=0.0003). [Obesity (Silver Spring) 2020;28:529-536]
More individuals on liraglutide-IBT than placebo-IBT achieved weight loss of ≥5 percent from baseline at week 56 (61.5 percent vs 38.8 percent; odds ratio [OR], 2.5 percent; p=0.0003), including >10 percent weight loss (30.5 percent vs 19.8 percent; OR, 1.8 percent; p=0.0469) and >15 percent weight loss (18.1 percent vs 8.9 percent; OR, 2.3 percent; p=0.0311).
Individuals on liraglutide-IBT also incurred greater improvements in waist circumference (-9.4 vs -6.7 cm; p=0.0063), HbA1c (-0.2 percent vs -0.1 percent; p=0.0008), and fasting plasma glucose (-0.2 vs 0.01 mmol/L; p=0.0002) at week 56 vs those on placebo-IBT.
Individuals in both groups experienced improvements in physical function with no significant difference between groups.
There were no new safety signals identified with liraglutide. The most common adverse event (AE) experienced in both groups was gastrointestinal AEs (71.1 and 48.6 percent for liraglutide-IBT and placebo-IBT, respectively). Nausea occurred more frequently in liraglutide-IBT than placebo-IBT recipients (47.9 percent vs 17.9 percent). Serious AEs occurred in 4.2 and 1.4 percent of the respective groups, while neoplasms were more common in the liraglutide-IBT than placebo-IBT group (n=16 vs 7).
“Findings from the present SCALE IBT study … show that approximately half of participants can achieve the CMS#-IBT weight-loss criterion (≥3 kg) at 6 months with brief counselling, which can be further increased when combined with the addition of liraglutide 3.0 mg,” said the researchers.
However, the results do not provide insight into the exact amount of IBT required in combination with liraglutide to produce clinically meaningful weight loss.
“The results from this study [also] raise questions concerning the extent to which high-intensity behavioural counselling [14–15 sessions in 6 months], as compared with less intensive lifestyle intervention [monthly counselling], contributes to additional weight loss with liraglutide 3.0 mg,” they added, noting that ongoing and future studies should address this question.