MedTrace Logo

Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity

NCT04881799 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-05-22

Study results available
· View outcomes & findings →

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

  • Pediatric Obesity

Interventions

DRUG

Phentermine/Topiramate (Qsymia)

Oral pill taken once in the morning. Treatment will initiate with 3.75 mg/23 mg for 14 days, then increased to 7.5 mg/46 mg for 14 days, then increased to 11.25 mg/69 mg for 14 days then increased to the final dose of 15 mg/92 mg.

DRUG

Placebo

Matching placebo taken orally once in the morning.

Sponsors & Collaborators

Principal Investigators

  • Megan Bensignor, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-07
Primary Completion
2025-10-27
Completion
2026-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04881799 on ClinicalTrials.gov