A Phase 2 interventional study of Weight loss with pharmacotherapy and Weight loss without pharmacotherapy in Severe Obesity, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-03.
Sponsored by University of Minnesota · Phase 2, Interventional, and Treatment
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.
Primary Objective Evaluate the effect of GLP-1RA treatment on the maintenance of weight loss and durability of cardiometabolic risk factor improvements among adolescents with severe obesity following a meal replacement induction period. The investigators hypothesize that adolescents with severe obesity receiving GLP-1RA treatment following a short-term meal replacement induction period will demonstrate superior maintenance of initial BMI reduction 52 weeks following randomization compared to those assigned to placebo (primary endpoint) and that a higher proportion of those assigned to GLP-1RA treatment vs. placebo will maintain ≥5% BMI reduction from baseline to the 52-week time point (secondary endpoint).
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 100 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Minnesota is the lead sponsor of 1,185 studies on the registry; 196 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 92 (70%) have results posted.
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Exclusion Criteria:
Individuals who, after a short-term (1-3 month) meal replacement induction period, achieve ≥5% BMI reduction. A selection of these participants are then randomized to receive treatment with placebo.
Drug: Weight loss without pharmacotherapy
Individuals who, after a short-term (1-3 month) meal replacement induction period, achieve a \>/= 5% BMI reduction. A selection of these participants are then randomized to receive treatment with GLP-1RA.
Drug: Weight loss with pharmacotherapy
Participants randomized to the drug intervention group will receive Exenatide extended-release.
Also known as: Exenatide extended release
Participants randomized to the placebo group will receive a placebo.
Also known as: Placebo
Body Mass Index
Percentage of body mass index change from Randomization to Week 52
Time frame: 52 weeks
100 participants consented to enroll in the study and entered the screening phase. During the screening phase participants entered and 8-week meal replacement therapy phase to help them meet a goal of achieving reducing their body mass by 5% or more. Only those participants who met this weight loss goal passed the study screening and were allowed to be randomized to receive placebo or GLP-1 RA. 66 participants met the BMI weight loss goal, 34 participants did not pass the screening phase.
| Milestone | Weight Loss Maintenance Without Pharmacotherapy | Weight Loss Maintenance With Pharmacotherapy |
|---|---|---|
| Started | 33 | 33 |
| Completed | 26 | 30 |
| Not completed | 7 | 3 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Withdrawal by subject | 5 | 2 |
Percentage of body mass index change from Randomization to Week 52
| percentage (body mass index) | Weight Loss Maintenance Without Pharmacotherapy | Weight Loss Maintenance With Pharmacotherapy |
|---|---|---|
| Body Mass Index | 10.1 ± 9.0 | 4.6 ± 10.5 |
Collected over Adverse event and serious adverse event data was collected from Baseline to Week 52.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Weight Loss Maintenance Without Pharmacotherapy | 0/33 (0%) | 0/33 (0%) | 30/33 (90.9%) |
| Weight Loss Maintenance With Pharmacotherapy | 0/33 (0%) | 1/33 (3%) | 32/33 (97%) |
| Meal Replacement Induction | 0/100 (0%) | 0/100 (0%) | 0/100 (0%) |
| Event | Weight Loss Maintenance Without Pharmacotherapy | Weight Loss Maintenance With Pharmacotherapy | Meal Replacement Induction |
|---|---|---|---|
| Hospitalization for chemical dependencyInjury, poisoning and procedural complications | 0/33 | 1/33 | — |
| Event | Weight Loss Maintenance Without Pharmacotherapy | Weight Loss Maintenance With Pharmacotherapy | Meal Replacement Induction |
|---|---|---|---|
| Injection Site ReactionSkin and subcutaneous tissue disorders | 24/33 | 26/33 | — |
| HeadacheGeneral disorders | 14/33 | 19/33 | — |
| NauseaGastrointestinal disorders | 7/33 | 13/33 | — |
| VomitingGeneral disorders | 2/33 | 13/33 | — |
| Upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 13/33 | 7/33 | — |
| DiarrheaHepatobiliary disorders | 6/33 | 11/33 | — |
| ConstipationHepatobiliary disorders | 6/33 | 6/33 | — |
| DyspepsiaGastrointestinal disorders | 4/33 | 5/33 | — |
| DizzinessNervous system disorders | 3/33 | 4/33 | — |
| Flu-like symptomsImmune system disorders | 4/33 | 3/33 | — |
| Age, Categorical(Participants) | Weight Loss Maintenance Without Pharmacotherapy | Weight Loss Maintenance With Pharmacotherapy | Total |
|---|---|---|---|
| <=18 years | 33 | 33 | 66 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Weight Loss Maintenance Without Pharmacotherapy | Weight Loss Maintenance With Pharmacotherapy | Total |
|---|---|---|---|
| Female | 13 | 18 | 31 |
| Male | 20 | 15 | 35 |
| Ethnicity (NIH/OMB)(Participants) | Weight Loss Maintenance Without Pharmacotherapy | Weight Loss Maintenance With Pharmacotherapy | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 5 | 7 |
| Not Hispanic or Latino | 31 | 27 | 58 |
| Unknown or Not Reported | 0 | 1 | 1 |
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