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Liraglutide 3.0 mg and Intensive Behavioral Therapy (IBT) for Obesity in Primary Care: The SCALE IBT Randomized Controlled Trial
Author(s) -
Wadden Thomas A.,
Tronieri Jena Shaw,
Sugimoto Danny,
Lund Michael Taulo,
Auerbach Pernille,
Jensen Camilla,
Rubino Domenica
Publication year - 2020
Publication title -
obesity
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.438
H-Index - 199
eISSN - 1930-739X
pISSN - 1930-7381
DOI - 10.1002/oby.22726
Subject(s) - liraglutide , medicine , placebo , weight loss , medicaid , randomized controlled trial , obesity , overweight , odds ratio , diabetes mellitus , physical therapy , type 2 diabetes , endocrinology , health care , alternative medicine , pathology , economic growth , economics
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.