Phase 2 Completed N=150 Randomized Quadruple-blind Treatment

SMART Use of Medication for the Treatment of Adolescent Severe Obesity

Adolescent Obesity

Source: ClinicalTrials.gov NCT04007393 ↗

Enrolled (actual)

150

Serious AEs

6.0%

Results posted

May 2026

Primary outcomePrimary: Percent Change in Body Mass Index (BMI) — -9.62; -12.27; -4.53; -2.53 % change in body mass index (BMI)

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Body Mass Index (BMI)	-9.62; -12.27; -4.53; -2.53; -12.36; -9.52	—

Eligibility Criteria

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 ( 1.2 mg/dL;
History of cholelithiasis;
History of nephrolithiasis;
Untreated thyroid disorder;
Hyperthyroidism;
Breastfeeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04007393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.