Medication + Lifestyle Changes for Adolescent Severe Obesity

(SMART Trial)

Overseen By Claudia Fox, MD, MPH

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Minnesota

Must not be taking: Weight loss drugs, ADHD stimulants

Disqualifiers: Diabetes, Cardiac disease, Schizophrenia, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Claudia Fox, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for teens aged 12-17 with severe obesity who haven't improved with lifestyle changes alone. They must be willing to use effective contraception if sexually active, and commit to the study's duration. Exclusions include diabetes, heart conditions, certain mental health issues, untreated thyroid disorders, previous weight loss surgery or medication use.

Inclusion Criteria

My BMI is at or above the lower of 1.2 times the 95th percentile or 35 Kg/m2.

Provision of signed and dated informed assent form

I am between 12 and 17 years old.

Exclusion Criteria

You smoke or use tobacco products.

I have a thyroid condition that hasn't been treated.

I have a seizure disorder, not just childhood febrile seizures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lifestyle Modification Therapy (LSMT)

Participants start with a lifestyle modification program to assess initial weight loss response

12-24 weeks

Regular visits for weight assessment

Pharmacotherapy Addition

Participants who do not achieve a 5% BMI reduction add phentermine to LSMT

12 weeks

Regular visits for weight assessment and medication adjustment

Advanced Pharmacotherapy

Participants who do not achieve a 5% BMI reduction with phentermine are randomized to additional medication regimens

12-24 weeks

Regular visits for weight assessment and medication adjustment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Phentermine Pill
• Topiramate Pill

Trial Overview The study tests how well adding obesity drugs Phentermine and Topiramate works after lifestyle modification therapy in adolescents. It looks at the best timing and sequence for introducing these medications when lifestyle changes aren't enough.

Participant Groups

Group I: LSMT x 24 weeks Experimental Treatment 3 Interventions

Participants in this arm will start LSMT at baseline and have a weight loss response assessment at T=24 weeks: if body mass index (BMI) is down 5% at T=24 weeks, the participant will continue with LSMT for the remainder of the study (i.e. for another 24 weeks); if BMI is not down 5% at T=24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT; i.e. at T=36 weeks. At T=36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study (i.e. for another 12 weeks); if BMI is not down by 5% at T=36 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study (i.e. for another 12 weeks).

Group II: LSMT x 12 weeks Experimental Treatment 3 Interventions

Participants in this arm will start LSMT at baseline and have a weight loss response assessment at T=12 weeks: if body mass index (BMI) is down 5% at T=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 T=12 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT; i.e. at T=24 weeks. At T=24 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study (i.e. for another 24 weeks); if BMI is not down by 5% at T=24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study (i.e. for another 24 weeks).

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+