Can a Weight-Loss drug stop obesity before it starts? new trial aims to find out
NCT ID NCT06905626
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug Qsymia, combined with lifestyle coaching, can prevent obesity in 140 adolescents and young adults (ages 18-25) who are overweight (BMI 25-30) and have a family history of obesity. Participants will receive either Qsymia or a placebo, plus coaching on diet and exercise, for about one year. The main goal is to see if the drug helps maintain a healthy body mass index.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Qsymia (phentermine and topiramate extended-release)
- What this could lead to
- If successful, this could provide a proven way to prevent obesity in young people at high risk, reducing future health problems.
- What could go wrong
- This is a relatively small Phase 3 trial, and the drug may cause side effects. Results may not apply to all groups, and long-term safety is still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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