Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Early Phase 1 study of Pediatric Obesity, sponsored by University of Minnesota.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The percent change in body mass index (BMI) from Baseline to Month 6 will be calculated. BMI is defined as a person's weight in kilograms divided by the square of height in meters. The Phase 1 (double-blind) portion of the study was six months and data were collected at the end of the 6 month double-blind phase.
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 |
What the registry record for NCT04881799 still lists
NCT04881799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 230-participant average among 45 other Pediatric Obesity trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Pediatric Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04881799's enrollment target sits among peer trials
13 46th of 45 the lowest of 45 other Pediatric Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pediatric Obesity 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
-
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
RECRUITING · NA
-
iAmHealthy Clinical Practice Guideline (CPG)
RECRUITING · NA
-
Monitoring Eating Across Locations (MEAL) - Timing, Intake, and Mealtime Evaluation (TIME)
RECRUITING · NA
-
Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health
RECRUITING · NA
-
Growing Healthy Children and Families in Rural Arkansas
RECRUITING · NA
-
Time Limited Eating in Adolescents With Type 2 Diabetes (KT2D)
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03125655 · 13 participants
Regulation of Inflammatory Genes in Psoriasis
- NCT03774446 · 13 participants · Phase 2
Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
- NCT03830151 · 13 participants · Phase 1
Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
- NCT04573231 · 13 participants · Phase 2
Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI