Adolescent ObesityPhase 2SMARTNCT04007393

SMART Use of Medication for the Treatment of Adolescent Severe Obesity

A Phase 2 study testing Lifestyle Modification Therapy (LSMT), Phentermine Pill and Topiramate Pill in people with Adolescent Obesity, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Adolescent Obesity
What is being tested?: Lifestyle Modification Therapy (LSMT), Phentermine Pill and Topiramate Pill
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 siteUnited States
Study dates: 21 Nov 2019to 11 Mar 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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;

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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
History of or current diagnosis of schizophrenia, psychosis, mania, chemical dependency;
Unstable depression or anxiety that has required hospitalization in the past year;
Any history of suicide attempt;
Suicidal ideation or self-harm within 12 months prior to enrollment;
Bicarbonate < 18 mmol/L;
Creatinine > 1.2 mg/dL;
History of cholelithiasis;
History of nephrolithiasis;
Untreated thyroid disorder;
Hyperthyroidism;
Breastfeeding

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Minnesota
Minneapolis, Minnesota, 55414

Other trials in United States

About this study

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.

Read the 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.

Conditions: Adolescent Obesity
Being tested: Lifestyle Modification Therapy (LSMT), Phentermine Pill, Topiramate Pill, Placebo
Medical subject headings: Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lifestyle Modification Therapy (LSMT)Behavioural
LSMT will consist of both in-person and by telephone sessions delivered throughout the 48-week intervention phase. Each session will last 30-60 minutes. A trained study coordinator (a registered dietician or someone trained by our registered dietician) will deliver therapy which consists of counseling using education, goal setting and barrier reduction. Participants will be randomized to receive LSMT for 12 or 24 weeks before a re-assessment of their BMI.
Phentermine PillDrug
Phentermine will be started only if a participant does not lose 5% of BMI after 12 or 24 weeks of LSMT. Subjects will take 15 mg of phentermine every morning for 12 weeks at which time there will be an assessment of weight loss. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study (through week 48) along with their LSMT.
Topiramate PillDrug
Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Topiramate dosing will begin at 50 mg every morning for the first 7 days, and then increase to 100 mg every morning through week 48. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue.
PlaceboDrug
Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Participants will take a placebo pill every morning.

Study groups in NCT04007393
Study group	Role	What they receive
LSMT 12	Other	Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study (i.e. for another 36 weeks); if BMI is not down 5% at 12 weeks, the participant will add phentermine to LSMT (LSMT+phentermine) and undergo a second weight loss response assessment after 12 weeks. At 24 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with LSMT+Phentermine for the the remainder of study. If BMI is not down by 5% at 24 weeks, the participant will be randomized to LSMT+Phentermine+topiramate or LSMT+Topiramate+placebo for the duration of the study. Receives: Behavioral: Lifestyle Modification Therapy (LSMT); Drug: Phentermine Pill; Drug: Topiramate Pill; Drug: Placebo
LSMT 24	Other	Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if body mass index (BMI) is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study. If BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (LSMT+phentermine) and undergo a second weight loss response assessment after 12 weeks. At 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with LSMT+Phentermine for the the remainder of study. If BMI is not down by 5% at 24 weeks, the participant will be randomized to LSMT+Phentermine+topiramate or LSMT+Topiramate+placebo for the duration of the study. Receives: Behavioral: Lifestyle Modification Therapy (LSMT); Drug: Phentermine Pill; Drug: Topiramate Pill; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Body Mass Index (BMI)
The outcome values represent percent change in BMI from baseline to week 48.
Measured: Baseline to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 201911 Mar 2025

First posted5 Jul 2019
Study start21 Nov 2019
Primary completion11 Mar 2025
Study completion11 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adolescent ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: 2-staged sequential multiple assignment randomized trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04007393
Sponsor's protocol ID: PEDS-2019-26512
Other IDs: 1R01DK119456
Acronym: SMART
Status last verified: Apr 2026
First submitted: 28 Jun 2019
Last updated: 5 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified IPD may be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Adolescent Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SMART Use of Medication for the Treatment of Adolescent Severe Obesity
ClinicalTrials.gov ID: NCT04007393
Acronym / sponsor ID: SMART / PEDS-2019-26512
Conditions: Adolescent Obesity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 21 Nov 2019 (actual)
Primary completion: 11 Mar 2025 (actual)
Study completion: 11 Mar 2025 (actual)
First posted: 5 Jul 2019 (actual)
Results: Posted 5 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: 2-staged sequential multiple assignment randomized trial

Arm	Type	Receives
LSMT 12	Other	Behavioral: Lifestyle Modification Therapy (LSMT), Drug: Phentermine Pill, Drug: Topiramate Pill, Drug: PlaceboParticipants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study (i.e. for another 36 weeks); if BMI is not down 5% at 12 weeks, the participant will add phentermine to LSMT (LSMT+phentermine) and undergo a second weight loss response assessment after 12 weeks. At 24 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with LSMT+Phentermine for the the remainder of study. If BMI is not down by 5% at 24 weeks, the participant will be randomized to LSMT+Phentermine+topiramate or LSMT+Topiramate+placebo for the duration of the study.
LSMT 24	Other	Behavioral: Lifestyle Modification Therapy (LSMT), Drug: Phentermine Pill, Drug: Topiramate Pill, Drug: PlaceboParticipants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if body mass index (BMI) is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study. If BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (LSMT+phentermine) and undergo a second weight loss response assessment after 12 weeks. At 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with LSMT+Phentermine for the the remainder of study. If BMI is not down by 5% at 24 weeks, the participant will be randomized to LSMT+Phentermine+topiramate or LSMT+Topiramate+placebo for the duration of the study.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (21 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lifestyle Modification Therapy (LSMT)LSMT will consist of both in-person and by telephone sessions delivered throughout the 48-week intervention phase. Each session will last 30-60 minutes. A trained study coordinator (a registered dietician or someone trained by our registered dietician) will deliver therapy which consists of counseling using education, goal setting and barrier reduction. Participants will be randomized to receive LSMT for 12 or 24 weeks before a re-assessment of their BMI.	Behavioural	LSMT 12, LSMT 24
Phentermine PillPhentermine will be started only if a participant does not lose 5% of BMI after 12 or 24 weeks of LSMT. Subjects will take 15 mg of phentermine every morning for 12 weeks at which time there will be an assessment of weight loss. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study (through week 48) along with their LSMT.	Drug	LSMT 12, LSMT 24
Topiramate PillParticipants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Topiramate dosing will begin at 50 mg every morning for the first 7 days, and then increase to 100 mg every morning through week 48. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue.	Drug	LSMT 12, LSMT 24
PlaceboParticipants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Participants will take a placebo pill every morning.	Drug	LSMT 12, LSMT 24

Primary outcome

Percent Change in Body Mass Index (BMI)
Time frame: Baseline to Week 48
The outcome values represent percent change in BMI from baseline to week 48.

Results and safety

Results posted to the registry on 5 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: LSMT 12	11	11
Arm 1: LSMT 12 + Phentermine	24	24
Arm 1: LSMT 12+Phentermine+Topiramate	20	19
Arm 1: LSMT 12+ Topiramate + Placebo	21	20
Arm 2: LSMT 24	16	11
Arm 2: LSMT 24 + Phentermine	19	17
Arm 2: LSMT 24+Phentermine+Topiramate	20	20
Arm 2: LSMT+Topiramate+Placebo	19	19

Primary outcome: Percent Change in Body Mass Index (BMI)

Time frame: Baseline to Week 48. Mean (Standard Deviation). Unit: % change in body mass index (BMI)

Measure	LSMT 12 n = 11	LSMT 12+Phentermine n = 24	LSMT 12+Phentermine+Topiramate n = 19	LSMT 12+Topiramate+Placebo n = 20	LSMT 24 n = 11	LSMT 24+Phentermine n = 17	LSMT 24+Phentermine+Topiramate n = 20	LSMT+Topiramate+Placebo n = 19
Value	-9.62 (7.00)	-12.27 (8.2)	-4.53 (8.42)	-2.53 (5.97)	-12.36 (7.71)	-9.52 (5.17)	-3.45 (5.11)	-0.30 (5.05)

Adverse events

Time frame: Adverse event data were collected Randomization through Week 48.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: LSMT x 12	1 of 11 (9.1%)	11 of 11 (100%)	0 of 11
Arm 1: LSMT 12 +Phentermine	2 of 24 (8.3%)	20 of 24 (83.3%)	0 of 24
Arm 1: LSMT +12+Phentermine+Topiramate	3 of 20 (15%)	20 of 20 (100%)	0 of 20
Arm 1: LSMT 12+Phentermine+Placebo	1 of 21 (4.8%)	21 of 21 (100%)	0 of 21
Arm 2: LSMT x 24	2 of 16 (12.5%)	16 of 16 (100%)	0 of 16
Arm 2: LSMT 24+Phentermine	0 of 19 (0%)	19 of 19 (100%)	0 of 19
Arm 2: LSMT 24X Phentermine+Topiramate	0 of 20 (0%)	20 of 20 (100%)	0 of 20
Arm 2: LSMT 24+Phentermine+Placebo	0 of 19 (0%)	19 of 19 (100%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified IPD may be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Claudia Fox, MD, MPH principal investigator

University of Minnesota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lifestyle Modification Therapy (LSMT), Phentermine Pill and Topiramate Pill in people with Adolescent Obesity, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Body Mass Index (BMI) (time frame: Baseline to Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04007393.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.