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Qsymia for Weight Gain Prevention

AK
LH
Overseen ByLisa Hostetler
Age: 18 - 65
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Minnesota
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AK

Aaron Kelly, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for young adults ages 18 to 25 who are overweight (BMI between 25 and 30) and have a family history of obesity. Participants must be otherwise healthy.

Inclusion Criteria

BMI between 25 and less than 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) with parental obesity status confirmed by release of information to review electronic health record
I am between 18 and 25 years old.

Exclusion Criteria

Alanine transaminase (ALT) or aspartate transaminase (AST) >= 2.5 times the upper limit of normal
Known hypersensitivity to sympathomimetic amines
I have been treated with growth hormone in the past.
See 30 more

What Are the Treatments Tested in This Trial?

Interventions

  • Qsymia

Trial Overview

The study compares the weight gain prevention effects of Qsymia (a prescription medication) versus a placebo, along with lifestyle coaching, in adolescents and young adults at risk for obesity.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Qsymia armExperimental Treatment1 Intervention
Group II: Placebo armPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

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