CompletedPhase 2

SMART Use of Medication for the Treatment of Adolescent Severe Obesity

United States150 participantsStarted 2019-11-21

Plain-language 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.

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent Change in Body Mass Index (BMI)

Timeframe: Baseline to Week 48

Trial details

NCT IDNCT04007393

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-11

Results submitted2026-03-13

View on ClinicalTrials.gov More Adolescent Obesity trials

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.