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NCT04298203 · ClinicalTrials.gov registry record · Phase 2
Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents With Severe Obesity
A Phase 2 study of Obesity, sponsored by University of Minnesota.
- Active
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04298203 is a Phase 2 study of Obesity that is active but no longer recruiting, run by University of Minnesota. The registered enrollment target is 100 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04298203, a Phase 2 study of Obesity, is active but no longer recruiting, sponsored by University of Minnesota.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Long-term weight loss maintenance is seldom achieved by individuals with obesity owing to numerous biological adaptations occurring in the post-weight loss setting, including neuroendocrine-mediated changes in appetite/satiety and reduction of energy expenditure. Following weight loss, peripheral and central mechanisms respond in a way similar to starvation by conveying a sense that energy reserves have dwindled, activating a strong counter-response to increase caloric intake. Moreover, metabolic rate drops, further compounding the propensity for weight rebound. Adolescents with severe obesity are not immune to the vexing issue of weight regain; therefore, effective and scalable treatments are urgently needed. Pharmacotherapy has the potential to prevent weight regain by targeting counter-regulatory mechanisms in the post-weight loss setting. Unfortunately, only one obesity medication is FDA-approved for long-term use in adolescents and is seldom prescribed owing to modest efficacy and notable side effects. Among the most promising candidates in the pediatric pipeline is the combination of phentermine and topiramate, which is the most effective adult weight loss medication currently available. The mechanisms of action are thought to reduce appetite, enhance satiety, and potentially increase energy expenditure, making this medication particularly well-suited for the purpose of weight loss maintenance since it targets many of the biological adaptations known to induce relapse and subsequent weight regain. The investigators have generated preliminary data demonstrating that both phentermine and topiramate reduce BMI in adolescents with severe obesity and have acceptable safety profiles. In this clinical trial, the investigators will utilize combination phentermine/topiramate to target counter-regulatory pathways responsible for weight regain after meal replacement therapy (structured meals of known caloric content) in adolescents with severe obesity with a goal of enha
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Phentermine-Topiramate
- DIETARY_SUPPLEMENT Meal Replacement Therapy
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-08-04 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04298203
The ClinicalTrials.gov registry entry for NCT04298203 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (88% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04298203 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT04298203 about?
NCT04298203 is a clinical study titled "Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents With Severe Obesity". Long-term weight loss maintenance is seldom achieved by individuals with obesity owing to numerous biological adaptations occurring in the post-weight loss setting, including neuroendocrine-mediated changes in appetite/satiety and reduction of energy expenditure. Following weight loss, peripheral an...
What is the current status of trial NCT04298203?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2021-08-04. Estimated completion is 2027-06-30.
What conditions does trial NCT04298203 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT04298203?
The interventions under investigation include: Placebo (OTHER), Phentermine-Topiramate (DRUG), Meal Replacement Therapy (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04298203?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04298203 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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