Liraglutide 3.0 mg and Intensive Behavioral Therapy (IBT) for Obesity in Primary Care: The SCALE IBT Randomized Controlled Trial

Abstract

Objective Previous studies have shown additive weight loss when intensive behavioral therapy (IBT) was combined with weight‐loss medication. The present multisite study provides the first evaluation, in primary care, of the effect of the Centers for Medicare and Medicaid Services–based IBT benefit, delivered alone (with placebo) or in combination with liraglutide 3.0 mg. Methods The Satiety and Clinical Adiposity—Liraglutide Evidence in individuals with and without diabetes (SCALE) IBT was a 56‐week, randomized, double‐blind, placebo‐controlled, multicenter trial in individuals with obesity who received liraglutide 3.0 mg (n = 142) or placebo (n = 140) as an adjunct to IBT. Results At week 56, mean weight loss with liraglutide 3.0 mg plus IBT was 7.5% and 4.0% with placebo combined with IBT (estimated treatment difference [95% CI]–3.4% [–5.3% to –1.6%], P = 0.0003). Significantly more individuals on liraglutide 3.0 mg than placebo achieved ≥ 5% weight loss (61.5% vs. 38.8%; odds ratio [OR] 2.5% [1.5% to 4.1%], P = 0.0003), > 10% weight loss (30.5% vs. 19.8%; OR 1.8% [1.0% to 3.1%], P = 0.0469), and > 15% weight loss (18.1% vs. 8.9%; OR 2.3% [1.1% to 4.7%], P = 0.0311). Liraglutide 3.0 mg in combination with IBT was well tolerated, with no new safety signals identified. Conclusions In a primary care setting, Centers for Medicare and Medicaid Services–based IBT produced clinically meaningful weight loss at 56 weeks, enhanced by the addition of liraglutide 3.0 mg.

Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial

“…IBT consisted of a hypocaloric diet, increased physical activity, and behavioral therapy delivered in frequent counseling sessions and is described in detail elsewhere (21) and in the Supplementary Data. Individuals attended a total of 23 individual or group counseling sessions during the 56-week period, delivered by a registered dietitian or similarly qualified health care professional.…”

Effects of Dietary Self-Monitoring, Physical Activity, Liraglutide 3.0 mg, and Placebo on Weight Loss in the SCALE IBT Trial

“…Their mean ages were 45.5 (11.6) and 49.0 (11.2) years, 83.8 and 82.9% were female, and 78.9 and 82.1% were identified as white (19.0 and 15.7% as black), respectively. All other baseline demographics also were well matched between the treatment groups [9].…”

“…Participants were randomly assigned to either once-daily subcutaneous liraglutide 3.0 mg or placebo (1: 1 ratio). For full details of the SCALE IBT trial design, please refer to the primary publication, Wadden et al [9], 2019.…”

“…Several antiobesity medications have been approved by the Food and Drug Administration (FDA), including the glucagon-like peptide 1 receptor agonist, liraglutide 3.0 mg [6]. These medications increase average weight loss [7][8][9], but require individuals to make additional behavioral changes in order to adhere to a long-term medication regime.…”

“…SCALE IBT was a randomized clinical trial (ClinicalTrials.gov: NCT02963935) designed to assess the effects of liraglutide 3.0 mg versus placebo, both in combination with intensive behavioral therapy (IBT), on weight loss in individuals with obesity [9]. In the primary analysis, participants assigned to take liraglutide 3.0 mg as an adjunct to IBT lost a mean of 7.5% of their initial weight at week 56, compared with a significantly smaller 4.0% for those assigned to IBT with placebo ( p = 0.0003) [9]. The present pre-specified secondary analysis evaluated adherence throughout the 56-week trial to three treatment components: dietary self-monitoring, physical activity, and medication usage (i.e., liraglutide 3.0 mg or placebo).…”