SMART Use of Medication for the Treatment of Adolescent Severe Obesity (NCT04007393) | Clinical Trial Compass
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 range12 Years – 17 Years
SexALL
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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, …