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NCT02496611 · ClinicalTrials.gov registry record · Phase 2
Enhancing Weight Loss Maintenance With GLP-1RA (BYDUREON™) in Adolescents With Severe Obesity
A Phase 2 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT02496611: Completed Phase 2 study, sponsored by University of Minnesota.
NCT02496611 is a Phase 2 study that has completed, run by University of Minnesota. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02496611, a Phase 2 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study 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 rando
Primary Outcome
Percentage of body mass index change from Randomization to Week 52
Interventions
- DRUG Weight loss with pharmacotherapy
- DRUG Weight loss without pharmacotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2015-12 |
| Est. Completion | 2020-08-14 |
| Phase | Phase 2 |
What the finished NCT02496611 record still lists
NCT02496611 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Weight loss with pharmacotherapy is the first listed.
NCT02496611 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02496611 about?
NCT02496611 is a clinical study titled "Enhancing Weight Loss Maintenance With GLP-1RA (BYDUREON™) in Adolescents With Severe Obesity". 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 energ...
What is the current status of trial NCT02496611?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2015-12. Estimated completion is 2020-08-14.
What interventions are being tested in trial NCT02496611?
The interventions under investigation include: Weight loss with pharmacotherapy (DRUG), Weight loss without pharmacotherapy (DRUG).
Who is sponsoring clinical trial NCT02496611?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02496611's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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