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NCT04881799 · ClinicalTrials.gov registry record · Early Phase 1
Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity
A Early Phase 1 study of Pediatric Obesity, sponsored by University of Minnesota.
- Active
- Registry status
- Early Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT04881799 is a Early Phase 1 study of Pediatric Obesity that is active but no longer recruiting, run by University of Minnesota. The registered enrollment target is 13 participants, below the 230-participant average among 45 other Pediatric Obesity trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04881799, a Early Phase 1 study of Pediatric Obesity, is active but no longer recruiting, sponsored by University of Minnesota.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
As the prevalence of obesity rises in the U.S., so does the incidence of pediatric type 2 diabetes (T2D), which is associated with more aggressive disease progression than in adults. From 2002-2012, the incidence of T2D in youth increased by 7% annually in the U.S. Compared to adults. T2D in adolescents is a much more progressive and recalcitrant disease, characterized by more rapid deterioration of β-cell function and earlier incidence of exogenous insulin dependence and diabetes-related comorbidities. A potential factor that drives the rapid progression of adolescent T2D is obesity (body mass index \[BMI\] \>95th percentile. Effective and safe treatments targeting both obesity and β-cell dysfunction are needed for pediatric T2D. In 2012, the FDA approved the use of Phentermine/Topiramate for the treatment of obesity in adults. This orally-administered medication is available in mid- (phentermine 7.5 mg; topiramate 46 mg) and high- (phentermine 15 mg; topiramate 92 mg) doses, administered once per day. In a meta-analysis, phentermine/topiramate was shown to be one of the most effective obesity medication currently available. A large dose-ranging trial in adults evaluating phentermine and topiramate as monotherapies vs. phentermine/topiramate demonstrated superior efficacy of the combination with an acceptable safety profile. Results from a large phase III clinical trial demonstrated placebo-subtracted weight loss of \>9% with treatment for one year at the top dose. Importantly, a separate trial demonstrated that the treatment effect is durable out to at least two years.41 The most common side effects in these trials were paresthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth. Improvements were noted in blood pressure, lipids, glucose, insulin, HOMA-IR, C-reactive protein, and adiponectin.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Phentermine/Topiramate (Qsymia)
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2022-07-07 |
| Est. Completion | 2026-10-27 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04881799
The ClinicalTrials.gov registry entry for NCT04881799 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 230-participant average among 45 other Pediatric Obesity trials with a reported enrollment target (94% 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 Pediatric Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04881799 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT04881799 about?
NCT04881799 is a clinical study titled "Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity". As the prevalence of obesity rises in the U.S., so does the incidence of pediatric type 2 diabetes (T2D), which is associated with more aggressive disease progression than in adults. From 2002-2012, the incidence of T2D in youth increased by 7% annually in the U.S. Compared to adults. T2D in adolesc...
What is the current status of trial NCT04881799?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 13 participants. The study started on 2022-07-07. Estimated completion is 2026-10-27.
What conditions does trial NCT04881799 study?
This clinical trial studies the following conditions: Pediatric Obesity.
What interventions are being tested in trial NCT04881799?
The interventions under investigation include: Placebo (DRUG), Phentermine/Topiramate (Qsymia) (DRUG).
Who is sponsoring clinical trial NCT04881799?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04881799 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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