Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers

Ken Fujioka, Patrick M O'Neil, Melanie Davies, Frank Greenway, David C W Lau, Birgitte Claudius, Trine Vang Skjøth, Christine Bjørn Jensen, John P H Wilding, Ken Fujioka, Patrick M O'Neil, Melanie Davies, Frank Greenway, David C W Lau, Birgitte Claudius, Trine Vang Skjøth, Christine Bjørn Jensen, John P H Wilding

Abstract

Objective: To identify an early response criterion for predicting ≥5% weight loss with liraglutide 3.0 mg at week 56 and to compare efficacy outcomes in early responders (ERs) and early nonresponders (ENRs).

Methods: Using pooled data from the SCALE Obesity and Prediabetes and SCALE Diabetes trials, weight loss of ≥4% at 16 weeks best predicted ≥5% weight loss after 56 weeks. Weight loss and changes in cardiometabolic risk factors and health-related quality of life were evaluated in ERs (≥4% weight loss at week 16) and ENRs (<4% weight loss at week 16) completing 56 weeks' treatment.

Results: Proportions of ERs/ENRs to liraglutide 3.0 mg were 77.3%/22.7% (individuals without type 2 diabetes, T2D) and 62.7%/37.3% (those with T2D). Greater mean weight loss was observed in ERs versus ENRs: 10.8% versus 3.0% (without T2D) and 8.5% versus 3.1% (T2D). In both trials, greater proportions of ERs versus ENRs achieved ≥5%, >10%, and >15% weight loss at week 56 with liraglutide 3.0 mg. Greater improvements in cardiometabolic risk factors and health-related quality of life scores were observed in ERs versus ENRs.

Conclusions: The early response criterion was clinically useful to identify individuals who would achieve clinically meaningful weight loss at 56 weeks.

Trial registration: ClinicalTrials.gov NCT01272219 NCT01272232.

© 2016 The Authors Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

Figures

Figure 1
Figure 1
Subject disposition for results of post hoc analyses. Early responders (ERs), individuals who achieved ≥4% weight loss from baseline at 16 weeks; early nonresponders (ENRs), individuals who achieved <4% weight loss from baseline at 16 weeks. Full analysis set (FAS): in order to be defined as ER/ENR at week 16, individuals had to have a fasting body weight measurement at baseline and the week 16 visit. Completers at week 56 were individuals with a body weight measurement at week 56. Only individuals satisfying the respective criteria are shown. [Color figure can be viewed at wileyonlinelibrary.com]
Figure 2
Figure 2
Fasting body weight loss by early responder status. Line graphs are observed means (±SE) for ERs/ENRs who completed 56 weeks. Fasting visit data only. ERs, early responders (individuals who achieved ≥4% weight loss from baseline at 16 weeks); ENRs, early nonresponders (individuals who achieved

Figure 3

Categorical weight loss at week…

Figure 3

Categorical weight loss at week 56. Proportions of subjects are estimated proportions from…

Figure 3
Categorical weight loss at week 56. Proportions of subjects are estimated proportions from a logistic regression model for ERs/ENRs who completed 56 weeks of treatment. ERs, early responders (individuals who achieved ≥4% weight loss from baseline at 16 weeks); ENR, early nonresponders (individuals who achieved
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Figure 3
Figure 3
Categorical weight loss at week 56. Proportions of subjects are estimated proportions from a logistic regression model for ERs/ENRs who completed 56 weeks of treatment. ERs, early responders (individuals who achieved ≥4% weight loss from baseline at 16 weeks); ENR, early nonresponders (individuals who achieved

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