Healthy Volunteers study: Qsymia
Official title Weight Gain Prevention in Adolescents and Young Adults
ClinicalTrials.gov ID: NCT06905626
What this study is testing
What is Qsymia 7.5 miligrams (mg)-46 mg Extended Release Capsule?
Qsymia 7.5 miligrams (mg)-46 mg Extended Release Capsule is an investigational medicine, taken by mouth, being studied as a potential treatment for healthy volunteers.
Also referred to as Qsymia.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 25. Healthy volunteers may be eligible.
You may be able to join 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).
You likely can't join 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.
- 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)
See the full eligibility 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).
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 25 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.