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Randomized Controlled Trial
. 2020 Mar;28(3):529-536.
doi: 10.1002/oby.22726.

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

Thomas A Wadden  1 , Jena Shaw Tronieri  1 , Danny Sugimoto  2 , Michael Taulo Lund  3 , Pernille Auerbach  3 , Camilla Jensen  3 , Domenica Rubino  4
Affiliations
Randomized Controlled Trial

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

Thomas A Wadden et al. Obesity (Silver Spring). 2020 Mar.

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.

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Conflict of interest statement

TW has received grants, on behalf of the University of Pennsylvania, from Novo Nordisk as well as honoraria from Novo Nordisk and WW (formerly Weight Watchers) for serving on scientific advisory boards. JST has received consulting fees/honoraria from Novo Nordisk. DS has received research grants from Novo Nordisk. DR has received grants from Obesinov SARL as well as consulting fees/honoraria from Novo Nordisk. MTL is an employee of Novo Nordisk and owns stock in the company. PA is an employee of Novo Nordisk. CJ is an employee of Novo Nordisk.

Figures

Figure 1
Figure 1
SCALE IBT study design. *IBT, intensive behavioral therapy, comprising behavioral counseling, a hypocaloric diet, and physical activity (building up from 100 to 250 minutes/week).
Figure 2
Figure 2
Patient disposition. *A given individual may be excluded for more than one reason. IBT, intensive behavioral therapy.
Figure 3
Figure 3
Change in body weight over time. Observed mean data ± SEM based on all in‐trial observations. Data from individuals who discontinued the trial product and returned for week 56 assessments are included. IBT, intensive behavioral therapy.
Figure 4
Figure 4
Weight loss of ≥ 5%, > 10%, or > 15% of baseline body weight at week 56. Data are for primary treatment policy estimand, logistic regression, J2R‐MI. IBT, intensive behavioral therapy; J2R‐MI, jump‐to‐reference multiple imputation.
See this image and copyright information in PMC

References

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