Recruiting
Phase 3

Obesity Prevention

Sponsor:

University of Minnesota

Code:

NCT06905626

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

Interventions

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

Placebo

Study Details

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.

Conditions

Healthy Volunteers

Study ID

NCT06905626

Start date

Jan 1, 2027

Status verified date

Nov, 2026

Completion date

Oct 31, 2031

Anticipated

Primary completion date

Oct 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Qsymia arm

Qsymia

placebo comparator: Placebo arm

Placebo

Interventions

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

Qsymia

Placebo

Placebo

Primary outcome measure

  • BMI [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Aaron Kelly, PhD

(612) 626-3492kelly105@umn.edu

Lisa Hostetler

(612) 6253261hoste005@umn.edu

Locations

University of Minnesota Center for Pediatric Obesity Medicine

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Samira Ahmed

ahmed787@umn.edu

Principal Investigator:

Aaron Kelly, PhD

More Information

Sponsor

University of Minnesota

Last update posted

Nov 4, 2026

Last verified

Nov, 2026

Keywords

  • Obesity prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.