Weight Loss in Primary Care Augmented by Liraglutide plus Behavior Therapy

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Adults with obesity seen in primary care lost more weight with a combination of the GLP-1 receptor agonist liraglutide and intensive behavioral therapy (IBT) than with behavioral therapy alone.

These findings, published February 24, 2020, in Obesity, are the result of the first primary careevaluation of the effect of the Centers for Medicare and Medicaid Services (CMS)-based IBT benefit.

A previous year-long open-label trial at a single site assessed the efficacy of CMS-based IBT alone vs IBT plus liraglutide in an obesity specialty setting. Results of that study support the efficacy of IBT for obesity and the potential benefit of adding medical therapy to this approach.

In the present study, researchers led by Thomas A. Wadden, PhD, professor of psychology in the department of psychiatry at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, enrolled 282 adults with obesity from 17 primary care sites.

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Eligibility: age ≥ 18 years, with stable body weight (maximum 5‐kg self‐
reported weightchange within 90 days before screening) and BMI ≥ 30 kg/m².
Key exclusion criteria included A1c ≥ 6.5%,type 1 or 2 diabetes, use
of medications (in the past 90 days) known to induce significant weight loss
or gain, inadequately treated hypertension, and history of cardiovascular disease.
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A daily injection of liraglutide 3.0 mg was randomly assigned to 142 participants (mean age, 45.4 years; 83.8% women) and a placebo regimen to 140 participants (mean age, 49 years; 82.9% women). All participants were monitored at clinic visits for response to treatment and received 23 brief (15-min) CMS-based IBT counseling sessions:

• Weekly during month 1

• Bi-weekly during months 2 to 6

• Monthly from months 7-13 (regardless of meeting CMS-required ≥3 kg during first 6 months)

The CMS-based IBT program reflects “an abbreviated lifestyle counseling protocol" adapted from the Diabetes Prevention Program (DPP) for delivery in primary care:

• 250 mins moderate-intensity physical activity per week (gradual increase from 100 min/week)

• Diets ranging from 1,200 or 1800 calories/day depending on baseline body weight.

• 23 15-minute counseling sessions with a dietitian who worked “incident to” a primary care provider.

Participant body weight was assessed at baseline, 16, 28 and 56 weeks; measures of waist circumference, A1c, and fasting plasma glucose (FPG) were taken at baseline and 56 weeks.

RESULTS - please click below for next page

Coprimary endpoints

Participants in the liraglutide group lost a mean of 7.5% of their baseline weight at 56 weeks, 3.4% greater than those assigned to placebo (P = .0003). Among participants assigned liraglutide, 61.5% lost at least 5% of baseline weight at 56 weeks vs 38.8% of those who received behavioral therapy alone (P=.0003).

Participants taking liraglutide were more than 2 times as likely to lose at least 5% of baseline body weight than participants assigned placebo (OR=2.5; 95% CI, 1.5-4.1). Participants assigned liraglutide were also more likely to lose more than 10% of baseline body weight (OR=1.8; 95% CI, 1-3.1) and more than 15% of baseline body weight (OR=2.3; 95% CI, 1.1-4.7) compared with those assigned placebo.

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Additional benefits. There was a significantly greater reduction in waist circumference among participants assigned liraglutide (9.4 cm at 56 weeks) vs those assigned placebo (6.7 cm [P=.0063]). A reduction in A1c of 0.2% among liraglutide-treated participants also was greater than that seen among those assigned placebo (0.1% [P=.0008]).
FPG in the liraglutide group dropped by 0.2 mmol/L vs a decrease in the placebo group of 0.01 mmol/L (P=.0002).

Although there were no significant differences observed between the treatment groups, improvements also
were seen in lipid levels and measures of systolic and diastolic blood pressure. 
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Importance of new data

Writing on the importance of the study’s contribution to current knowledge, the authors note it is the first randomized, placebo-controlled assessment of IBT plus medical therapy in primary care and across multiple practice sites.

Importantly the results demonstrate that clinically meaningful weight loss was achieved at 56 weeks by nearly 40% of participants in the placebo group – an achievement significantly augmented by the addition of liraglutide 3.0 mg.

A major limitation, the authors state in the study discussion, is inability to determine the precise amount of IBT needed to achieve clinically meaningful weight loss when combined with liraglutide 3.0 mg.