Enhancing Weight Loss Maintenance With GLP-1RA (BYDUREON™) in Adolescents With Severe Obesity
Status:
Completed
Trial end date:
2020-08-14
Target enrollment:
Participant gender:
Summary
Long-term weight loss maintenance is seldom achieved by individuals with obesity owing to
numerous biological adaptations involving appetite, satiety, and energy expenditure in the
post- weight loss setting. Following a loss in body weight, peripheral and central mechanisms
convey a sense that energy reserves have dwindled, activating a strong counter response to
increase caloric intake. Adolescents with severe obesity are not immune to the vexing issue
of weight regain. Indeed, only 2% are able to achieve and maintain clinically-meaningful
weight loss with lifestyle modification therapy. Therefore, novel treatment paradigms focused
on long-term weight loss maintenance are urgently needed. Pharmacotherapy has the potential
to prevent weight regain by targeting specific counter-regulatory mechanisms in the post-
weight loss setting. One of the most promising candidates is the glucagon like peptide-1
receptor agonist (GLP-1RA) class, which greatly enhanced weight loss maintenance following a
short-term low calorie diet among adults with obesity. The rationale for focusing on GLP-1RA
treatment (BYDUREON™) to prevent weight regain is supported by the multiple central and
peripheral mechanisms of action targeted by this class of drug; many of which specifically
address the biological adaptations known to induce relapse. The investigators have strong
preliminary data demonstrating that GLP-1RA treatment reduces BMI in adolescents with severe
obesity. Moreover, the investigators and others have shown that although meal replacement
therapy (structured meals of known caloric content) can elicit robust short-term weight loss
among adolescents with severe obesity, weight regain is a pervasive problem. Therefore, in
this clinical trial, our innovative approach will utilize GLP-1RA treatment to target weight
regain following short-term meal replacement therapy in youth with severe obesity.
Participants who achieve ≥5% BMI reduction during the meal replacement phase will be
randomized to GLP-1RA treatment or placebo for an additional 52 weeks while simultaneously
engaging in lifestyle modification therapy. Importantly, this study will also allow us to
examine the extent to which GLP-1RA treatment addresses mechanisms of weight regain,
investigate other pleiotropic benefits of GLP-1RA, and identify predictors of weight loss
response.
Phase:
Phase 2
Details
Lead Sponsor:
University of Minnesota University of Minnesota - Clinical and Translational Science Institute