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Can a Weight-Loss drug stop obesity before it starts? new trial aims to find out

NCT ID NCT06905626

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

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

18 to 25 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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