Status:
NOT_YET_RECRUITING
Weight Gain Prevention in Adolescents and Young Adults
Lead Sponsor:
University of Minnesota
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-25 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Once obesity develops and becomes entrenched, achieving sustained weight loss is extremely difficult. Thus, preventing the accumulation of excess adiposity in high-risk individuals is the ideal course...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2031
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06905626
Start Date
January 1 2026
End Date
May 31 2031
Last Update
July 11 2025
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