Suspended

PHARMATOPTopiramate for Weight Loss in Youth with Severe Obesity

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Study Aim

The study aims to evaluate if topiramate can help reduce body mass index in young individuals with severe obesity over three months.

What is being tested

Topiramate Tablets

Drug
Who is being recruted

Body Weight+6

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 12 to 18 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Early Phase 1
Interventional
Study Start: April 2022
See protocol details

Summary

Principal SponsorUniversity of Minnesota
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 4, 2022

Actual date on which the first participant was enrolled.

This study focuses on understanding how the drug Topiramate helps with weight loss in young people who have severe obesity. Topiramate is believed to reduce appetite, cravings, and certain eating habits, which may help with losing weight. Researchers aim to find out why Topiramate works better for some individuals than others, by looking at specific factors like age, body mass index (BMI), and sex. This is important because it could lead to more personalized treatments for young people struggling with obesity, potentially improving their health outcomes. Participants in the study will take Topiramate and have their drug levels monitored over a period of 3.5 months to see how it affects their weight and eating behaviors. The study will measure changes in BMI, which is a way to see how much weight a person has lost relative to their height. By using advanced models, researchers will analyze how the drug exposure correlates with changes in weight and eating patterns. This will help determine if certain characteristics make the drug more effective for some young individuals, paving the way for tailored obesity treatments. The study involves regular check-ins and measurements, ensuring safe monitoring of participants' health throughout the process.

Official TitlePharmacokinetics and Pharmacodynamics of Topiramate for Weight Loss in Youth: PHARMATOP
NCT04986631
Principal SponsorUniversity of Minnesota
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

62 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweightPediatric Obesity

Criteria

3 inclusion criteria required to participate
Body mass index (BMI) \</= 1.2 times the 95th percentile (age and sex-adjusted) and/or BMI \>/= 35 kg/m2

Ages 12 to \< 18 years old

Deemed appropriate candidates to receive topiramate (without contraindications) for weight loss by an obesity medicine specialist at the University of Minnesota

16 exclusion criteria prevent from participating
Baseline creatinine \> 1.2 mg/dL

History of metabolic/bariatric surgery

Obesity associated with a diagnosed genetic disorder (i.e. monogenic obesity, Prader-Willi, Bardet-Biedl syndrome)

Clinically diagnosed hyperthyroidism or uncontrolled hypothyroidism as determined by local medical monitor (who is a board certified endocrinologist)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Individuals will receive 75 mg of topiramate daily. The dose will start at 25 mg daily for the first week. The second week participants will receive 50 mg daily. Starting at week 3 participants will take 75 mg daily.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Minnesota

Minneapolis, United StatesOpen University of Minnesota in Google Maps
SuspendedOne Study Center