Weight Gain Prevention in Adolescents and Young Adults
Prevention of Obesity in Adolescents and Young Adults
1 other identifier
interventional
140
0 countries
N/A
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 healthy-volunteers
Started Jun 2026
Longer than P75 for phase_3 healthy-volunteers
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2025
CompletedFirst Posted
Study publicly available on registry
April 1, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2030
Study Completion
Last participant's last visit for all outcomes
March 31, 2031
February 17, 2026
February 1, 2026
3.8 years
February 4, 2025
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BMI
Change in body mass index
24 months
Secondary Outcomes (1)
Diet quality and eating behaviors
24 months
Study Arms (2)
Qsymia arm
EXPERIMENTALQsymia
Placebo arm
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Aaron Kelly, PhD
University of Minnesota
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- This study will have a 1:1 randomization. Participants will receive either Qsymia or a matching placebo.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2025
First Posted
April 1, 2025
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
March 31, 2030
Study Completion (Estimated)
March 31, 2031
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 10 years
- Access Criteria
- U of Minnesota Libraries
A long-term data sharing and preservation plan will be used to store and make publicly accessible the data beyond the life of the project. The deidentified data will be deposited into the Data Repository for University of Minnesota (DRUM). This University of Minnesota Libraries hosted institutional data repository is an open access platform for dissemination and archiving of university research data and is free to the University of Minnesota researchers. Curators review all incoming submissions and work with data authors to comply with data sharing requirements in ways that make data FAIR (Findable, Accessible, Interoperable, Reusable).