NCT04881799

Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity

Active, enrolled EARLY_PHASE1 Last updated 31 October 2025

What this trial tests

EARLY_PHASE1 trial testing Phentermine/Topiramate (Qsymia) in Pediatric Obesity in 13 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 July 2022

Primary endpoint
27 October 2025

27 October 2026

Quick facts

Lead sponsor	University of Minnesota
Phase	EARLY_PHASE1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	13
Start date	7 July 2022
Primary completion	27 October 2025
Estimated completion	27 October 2026
Sites	1 location across United States

Drugs / interventions tested

• Phentermine/Topiramate (Qsymia) — full drug profile →
• Placebo

Conditions studied

• Pediatric Obesity — all drugs for Pediatric Obesity →

Sponsor

University of Minnesota

Who can join

Adults 12 to 20, any sex, with Pediatric Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adolescents with Type 2 Diabetes: Overcoming Barriers to Effective Weight Management.
   Salama M, Biggs BK, Creo A, Prissel R, et al · · 2023 · cited 5× · PMID 36923685 · DOI 10.2147/dmso.s365829
2. Treatment of Youth-Onset Type 2 Diabetes: Focus on SGLT-2 Inhibitor Use.
   Arslanian S, Barrett T, Shehadeh N. · · 2026 · PMID 41930239 · DOI 10.1155/pedi/4555805
3. Extinguishing the Fire: Treating Pediatric Type 2 Diabetes by Targeting Obesity Treatment.
   Bensignor MO, Hsia DS, Van Name MA, Jastreboff AM, et al · · 2025 · PMID 40730197 · DOI 10.2337/dci25-0031