NCT06905626RecruitingPhase 3
Weight Gain Prevention in Adolescents and Young Adults
Prevention of Obesity in Adolescents and Young Adults
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 4 Feb 2025
- Start date
- 1 Jan 2027
- Primary completion date
- 31 Oct 2030
- Lead sponsor
- University of Minnesota
- Diseases
- Obesity
- NCT number
- NCT06905626
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 140
- From 1 Jan 2027 to the primary completion date, 31 Oct 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Current or recent (\<14 days prior to screening) use of monoamine oxidase inhibitor
- History of treatment with growth hormone
Other illness
- Diabetes (type 1 or 2)
- History of glaucoma
- Known hypersensitivity to sympathomimetic amines
- Eating disorder symptoms within 6 months and/or any past medical diagnosis of eating disorder
- Major psychiatric disorder
- History of suicide attempt
- History of seizures
- Uncontrolled hypertension
- History of structural heart defect
- History of clinically significant arrhythmia
- History of cholelithiasis
- History of nephrolithiasis
- Untreated thyroid disorder
Lab values
- 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)
Other
- Tanner stage 1-4
- Patient Health Questionnaire-9 (PHQ-9) score of \>/= 15 at screening
- Unstable clinically-diagnosed depression
- 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
- Diagnosed monogenic obesity
- Hyperthyroidism
Who the study is looking for
- 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.
Age in the registry: 18 years to 25 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota, Center for Pediatric Obesity Medicine Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.