Weight gain prevention in adolescents and young adults using low-dose pharmacotherapy plus lifestyle coaching

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 study examines a preventive strategy for obesity by combining lifestyle-based counseling with a low-dose anti-obesity medication in adolescents and young adults who are at risk for gaining excess weight. Eligible participants are healthy AYAs with overweight BMI and a family history of obesity. The study compares Qsymia extended-release to placebo, alongside structured weight gain prevention coaching. The goal is to see whether this pharmacologic approach can more effectively halt progression to obesity by targeting energy regulation pathways. Safety monitoring and efficacy outcomes will be collected to determine potential benefits and risks in this preventive setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 to M 25 at screening
* BMI \>/= 25 to \< 30 kg/m\^2
* Family history of obesity defined as one biological parent with severe obesity (BMI \>/= 35) and/or two biological parents with obesity (BMI \>/=30). Parental obesity status will be confirmed by obtaining a release of information to review and electronic health record.

Exclusion Criteria:

* Tanner stage 1-4
* Diabetes (type 1 or 2)
* Current or recent (\<6 months prior to screening) use of anti-obesity medication(s) or other weight-altering medication(s) (e.g. atypical anti-psychotics, attention deficit hyperactivity disorder (ADHD) stimulant)
* Previous bariatric surgery
* Current or recent (\<6 months prior to screening) use of medication(s) to treat insulin resistance
* Recent initiation (\<3 months prior to screening) of anti-hypertensive or lipid medication(s)
* History of glaucoma
* Current or recent (\<14 days prior to screening) use of monoamine oxidase inhibitor
* Known hypersensitivity to sympathomimetic amines
* History of treatment with growth hormone
* Patient Health Questionnaire-9 (PHQ-9) score of \>/= 15 at screening
* Eating disorder symptoms within 6 months and/or any past medical diagnosis of eating disorder
* Major psychiatric disorder
* Unstable clinically-diagnosed depression
* History of suicide attempt
* Suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at any time during the study
* Current pregnancy or breastfeeding
* Plans to become pregnant
* If sexually active, refusal to use 2 forms of birth control
* Tobacco use
* Alanine transaminase (ALT) or aspartate transaminase (AST) \>/= 2.5 times the upper limit of normal
* Bicarbonate 18 mmol/L
* Creatinine \> 1.2 mg/dL
* Creatinine clearance \<50 mL/min (Schwartz formula)
* History of seizures
* Uncontrolled hypertension
* History of structural heart defect
* History of clinically significant arrhythmia
* Diagnosed monogenic obesity
* History of cholelithiasis
* History of nephrolithiasis
* Hyperthyroidism
* Untreated thyroid disorder

Where it's running

• University of Minnesota Center for Pediatric Obesity Medicine
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Aaron Kelly, PhD — University of Minnesota
• Study coordinator: Aaron Kelly, PhD
• Email: kelly105@umn.edu
• Phone: (612) 626-3492

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.