Clinical trial

Weight Gain Prevention in Adolescents and Young Adults

Opening soon · Phase 3 · 0 countries · Registry ID NCT06905626

Opening soonPhase 3Interventional

What this study is about

The investigators believe they key to effective prevention of obesity is early identification of individuals at high risk of excess weight gain and proactive implementation of a comprehensive approach including lifestyle-based coaching and preventive medical management targeting the pathophysiology of dysregulated energy metabolism. In this study the investigators will take a fundamentally different approach to the science of obesity prevention by targeting the underlying biological processes driving unhealthy weight gain in adolescents/young adults (AYAs), a group that has been underrepresented in medication trials.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 25 Years
SexAll
Healthy volunteersAccepted
ConditionHealthy Volunteers

Full registry criteria

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

Treatments and study arms

Qsymia 7.5 miligrams (mg)-46 mg Extended Release Capsule

Drug

Qsymia

Placebo

Drug

Placebo

Primary outcomes

BMI24 months

Change in body mass index

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.