Dataset Information

Evaluating potential predictors of weight loss response to liraglutide in adolescents with obesity: A post hoc analysis of the randomized, placebo-controlled SCALE Teens trial.

ABSTRACT:

Background

As childhood obesity prevalence increases, determining which patients respond to anti-obesity medications would strengthen personalized approaches to obesity treatment. In the SCALE Teens trial among pubertal adolescents with obesity (NCT02918279), liraglutide 3.0 mg (or maximum tolerated dose) significantly reduced body mass index (BMI) standard deviation score on average versus placebo. That said, liraglutide effects on BMI reduction varied greatly among adolescents, similar to adults.

Objectives

To identify post hoc characteristics predictive of achieving ≥5% and ≥10% BMI reductions at 56 weeks with liraglutide versus placebo in adolescents from the SCALE Teens trial.

Methods

Logistic regression analysis was performed in 251 adolescents treated with liraglutide (n = 125) or placebo (n = 126) for 56 weeks. Baseline characteristics (selected a priori) included sex, race, ethnicity, age, Tanner (pubertal) stage, glycemic status (hyperglycemia [type 2 diabetes/prediabetes] vs. normoglycemia), obesity category (Class II/III vs. I), severity of depression symptoms (Patient Health Questionnaire-9), and weight variability (weight fluctuations over time). The effects of early responder status (≥4% BMI reduction at week 16) on week 56 response were assessed using descriptive statistics.

Results

Baseline characteristics did not affect achievement of ≥5% and ≥10% BMI reductions at week 56 in adolescents treated with liraglutide. Further, there was no association between weight variability and BMI reduction. Early liraglutide responders appeared to have greater BMI and body weight reductions at week 56 compared with early non-responders.

Conclusions

This secondary analysis suggests that adolescents with obesity may experience significant BMI reductions after 56 weeks of liraglutide treatment, regardless of their sex, race, ethnicity, age, pubertal stage, glycemic status, obesity category, severity of depression symptoms, or weight variability. Early response may predict greater week 56 response.

SUBMITTER: Bensignor MO

PROVIDER: S-EPMC10926323 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Publications

Evaluating potential predictors of weight loss response to liraglutide in adolescents with obesity: A post hoc analysis of the randomized, placebo-controlled SCALE Teens trial.

Bensignor Megan O MO Bramante Carolyn T CT Bomberg Eric M EM Fox Claudia K CK Hale Paula M PM Kelly Aaron S AS Mamadi Rashmi R Prabhu Nandana N Harder-Lauridsen Nina M NM Gross Amy C AC

Pediatric obesity 20230601 9

<h4>Background</h4>As childhood obesity prevalence increases, determining which patients respond to anti-obesity medications would strengthen personalized approaches to obesity treatment. In the SCALE Teens trial among pubertal adolescents with obesity (NCT02918279), liraglutide 3.0 mg (or maximum tolerated dose) significantly reduced body mass index (BMI) standard deviation score on average versus placebo. That said, liraglutide effects on BMI reduction varied greatly among adolescents, similar ...[more]

PMID: 37264767

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Project description:Abstract Background: Pediatric obesity is a chronic disease with rising prevalence and limited treatment options; first-line intervention is lifestyle therapy, which is typically unsuccessful.1 Liraglutide (3.0 mg) as an adjunct to lifestyle therapy has provided weight loss and improved cardiometabolic risk factors in adults.2 Here we report the results of liraglutide 3.0 mg in adolescents with obesity who failed to respond to lifestyle therapy. Methods: A multinational, randomized, double-blind trial (NCT02918279) with a 12-wk run-in of lifestyle therapy, 4-8-wk dose escalation, 52-wk maintenance period and 26-wk follow-up off trial drug. Adolescents aged 12-<18 years with obesity, stable weight and suboptimal response to lifestyle therapy alone were randomized 1:1 to once-daily subcutaneous liraglutide 3.0 mg (or maximum tolerated dose) or placebo (PBO), both as an adjunct to lifestyle therapy. Randomization was stratified by pubertal and glycemic (normal vs prediabetes/type 2 diabetes) status. Primary endpoint was change in BMI standard deviation score (SDS)3 from wk 0 to 56. Results: Of 125 adolescents randomized to liraglutide 3.0 mg and 126 to PBO, 101 and 100 completed treatment at wk 56, respectively; 99 in each arm completed the trial at wk 82. 40.6% were male; mean age 14.5 years; mean BMI 35.6 kg/m2; mean BMI SDS 3.17. Liraglutide 3.0 mg was superior to PBO for change in BMI SDS at wk 56 (estimated treatment difference [ETD] -0.22; 95% CI -0.37, -0.08; p=0.0022). In the liraglutide 3.0 mg vs PBO arm, 43.25% vs 18.73% (p=0.0002) and 26.08% vs 8.11% (p=0.0006) of adolescents had ≥5% and ≥10% reduction in baseline BMI at wk 56, respectively. A significant difference in change in BMI was seen for liraglutide 3.0 mg vs PBO: ETD -4.64%; 95% CI -7.14, -2.14; p=0.0003. A significant reduction in waist circumference with liraglutide 3.0 mg was shown at wk 56 (p=0.0126). Greater weight regain/rebound in BMI SDS at wk 82 was seen for liraglutide 3.0 mg vs PBO after drug discontinuation (ETD 0.15; 95% CI 0.07, 0.23; p=0.0002). There were no significant differences in blood pressure, fasting lipids, fasting plasma glucose or HbA1c at wk 56. No unexpected safety concerns and no severe hypoglycemia were reported. During treatment (0–56 wks), more adolescents in the liraglutide 3.0 mg (64.8%) vs PBO arm (36.5%) reported gastrointestinal adverse events (AEs), and 3 vs 5 adolescents, respectively, reported serious AEs. Mental health questionnaire results were similar in both arms at wk 56. No effect on growth or pubertal development was found. Conclusions: This trial demonstrates clinically meaningful4 weight loss in adolescents with obesity treated with liraglutide 3.0 mg as an adjunct to lifestyle therapy. The safety profile was similar to that observed in adults. References 1. Ryder et al Obesity 2018;26:951 2. Pi-Sunyer et al N Engl J Med 2015;373:11 3. EMA doc. ref. EMEA/402888/2008 4. Grossman et al JAMA 2017;317:2417

Project description:BackgroundThe worldwide prevalence of overweight and obesity is at alarming levels. Nearly one in three children in Europe is overweight or obese. Disordered eating and body image concerns are equally widespread and increase risk for more chronic and severe weight-related problems. Research has shown that online interventions that address both healthy weight regulation and body image can reduce risk for eating disorders and obesity simultaneously and are feasible to implement in school settings. To date, evaluation and dissemination of such programs in Europe is scant.MethodsThe Healthy Teens @ School study is a multi-country cluster-randomized controlled trial (RCT) comparing the effectiveness of an unguided, online, multi-level intervention for promoting a healthy lifestyle and reducing problematic eating behavior, eating disorder and obesity risk among students aged 14 to 19 years with control condition. As part of the Horizon 2020 funded project ICare (GA No. 634757) the trial is conducted in Austria and Spain. Cluster randomization by school is used. The intervention is an adapted version of an evidence-based program developed in the USA (StayingFit). Participants of the intervention group are assigned to one of two possible program tracks based on the results of the initial online-assessment: Overweight adolescents are assigned to the "Weight Management" track emphasizing balanced eating and exercise for weight maintenance, and all other individuals are assigned to the "Healthy Habits" track which aims at promoting healthy habits related to e.g., nutrition, physical activity, sleep. The participants of both tracks work on ten modules (one 20-30 min module per week) during school hours and/or at home. Assessments are conducted at pre- and post-intervention, and at 6- and 12-months after baseline assessment. The primary outcome is intuitive eating, secondary outcomes are eating disorder symptomatology, body image concerns, body mass index, food intake, physical activity, self-esteem, stress coping, depression, and anxiety. Following the initial assessment, individuals in the control group do not have access to the prevention program but continue as normal and are only prompted to the assessments at all time points. At the end of the 12-month study they will get access to the program.DiscussionThe results from this study will add to the understanding of how to address eating and weight related problems in adolescents and will shed light on the feasibility of implementing online prevention programs in school routine in Austria and Spain. As part of the larger ICare project this RCT will determine how an adapted version of StayingFit is disseminated within Europe.

Project description:IntroductionIndividuals who enroll in intensive behavioral therapy (IBT) programs are asked to make several lifestyle changes simultaneously. However, few studies have examined the relative effects of adherence to different treatment components on weight loss.ObjectiveThis secondary analysis of the SCALE IBT trial assessed adherence to the medication regimen, dietary self-monitoring, and physical activity recommendations and their relative contributions to weight change in individuals with obesity who were provided with IBT combined with either liraglutide 3.0 mg or placebo.MethodsSCALE IBT was a double-blinded, multicenter, randomized controlled trial comparing 56-week weight losses in individuals with obesity who received liraglutide 3.0 mg (n = 142) or placebo (n = 140), as an adjunct to IBT. Adherence to dietary self-monitoring, physical activity, and medication usage (liraglutide or placebo) were measured during the 56-week treatment period. A regression model was used to estimate the relative contribution of adherence to each treatment component to weight loss at week 56.ResultsThe proportion of individuals who adhered to each intervention component decreased over time. Compared with non-adherence, complete adherence to dietary self-monitoring and physical activity recommendations were associated with estimated weight changes of -7.2% (95% CI -10.4 to -4.0; p < 0.0001) and -2.0% (95% CI -3.2 to -0.8; p = 0.0009), respectively. Complete adherence to liraglutide predicted an additional weight loss of -6.5% (95% CI -10.2 to -2.9; p = 0.0005) relative to individuals who did not adhere to the medication regimen, while adherence to placebo did not have a statistically significant effect on weight loss (p = 0.33).ConclusionsHigh adherence to dietary self-monitoring and use of liraglutide 3.0 mg was associated with clinically relevant weight loss with IBT and adjunctive pharmacotherapy. The effect of adherence to physical activity was significant but smaller.

Dataset Information

Evaluating potential predictors of weight loss response to liraglutide in adolescents with obesity: A post hoc analysis of the randomized, placebo-controlled SCALE Teens trial.

Background

Objectives

Methods

Results

Conclusions

Publications

Evaluating potential predictors of weight loss response to liraglutide in adolescents with obesity: A post hoc analysis of the randomized, placebo-controlled SCALE Teens trial.

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