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SMART Use of Medication for the Treatment of Adolescent Severe Obesity | Clinical Trials | Clareo Health

COMPLETEDPHASE2

SMART Use of Medication for the Treatment of Adolescent Severe Obesity

NCT04007393•University of Minnesota

Summary

This study will examine the timing and sequence of using adjunct obesity pharmacotherapy for adolescents with severe obesity who do not respond to lifestyle modification therapy alone.

Detailed Description

This project is studying the best time to add weight loss medication to diet and exercise for helping adolescents who carry extra weight. All participants start with a lifestyle modification program and some participants may also receive study medication.Participants must be 12-17 years of age and carry extra weight. The program will last for 48 weeks.

Eligibility

Age

12 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provision of signed and dated informed assent form;
•Provision of signed and dated informed parental consent form from at least 1 legal parent/guardian;
•Stated willingness to comply with all study procedures and availability for the duration of the study;
•BMI \>/= 1.2 times the 95th percentile or BMI \>/= 35 Kg/m2, whichever is lower;
•Tanner stage \>/= 2;
•Male or female, aged 12-17 at time of consenting;
•For females of reproductive potential: when sexually active, agreement to use highly effective contraception (oral contraceptive pill, intra-uterine device (IUD), or implant) during study participation;
•For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

Exclusion Criteria

•Contraindications to phentermine or topiramate use according to package inserts, including: history of glaucoma; current or recent (\< 14 days) use of monoamine oxidase inhibitor; known hypersensitivity to sympathomimetic amines; current pregnancy, plans to become pregnant, or if sexually active refusal to use 2 forms of birth control; history of cardiac disease including coronary artery disease; clinically significant cardiac arrhythmias; heart failure or uncontrolled hypertension;
•Diabetes (type 1 or 2);
•Presence of cardiac pacemaker;
•Current or recent (\<6 months prior to enrollment) use of weight loss medication(s);
•Current use of weight-altering medication(s) (e.g., atypical antipsychotic, metformin) unless dose has been stable for past 6 months;
•Current use of other sympathomimetic amine such as attention-deficit hyperactivity disorder (ADHD) stimulants;
•Seizure disorder (other than infantile febrile seizure);
•Previous bariatric surgery;
•Recent initiation of change in dose (\< 3 months prior to enrollment) of anti-hypertensive or lipid medication(s);
•Tobacco use
+11 more criteria

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

November 21, 2019

Primary Completion Date

March 11, 2025

Completion Date

March 11, 2025

Last Updated

July 15, 2025

Enrollment

150

ACTUAL participants

Conditions

Adolescent Obesity

Interventions

Lifestyle Modification Therapy (LSMT)

BEHAVIORAL

Phentermine Pill

DRUG

Topiramate Pill

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SMART Use of Medication for the Treatment of Adolescent Severe Obesity

Inclusion Criteria

Exclusion Criteria

Self-Weighing for Adolescents Seeking Obesity Treatment

Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection

Improving Sleep, Decision-Making, and Eating in Adolescents with Obesity

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