Weight loss pill combo may help teens keep pounds off
NCT ID NCT04298203
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a combination of two weight-loss drugs, phentermine and topiramate, could help 100 teens with severe obesity keep weight off after losing it through a meal replacement program. The goal was to see if the medication could counteract the body's natural tendency to regain weight. The study focused on safety and changes in body fat, BMI, and related health measures.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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100 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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May 2026
- 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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12 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: * Severe obesity (BMI \>/= 120% of the 95th percentile or BMI \>/= 35 kg/m2) * Age 12 to \< 18 years of age at enrollment (screening) and Tanner stage \>/= 2 - Female participants who are sexually active with males and who are able to get pregnant must agree to use two forms of contraception throughout the trial Exclusion Criteria: * Diabetes (type 1 or 2) * Current or recent (\< six months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination phentermine/topiramate, liraglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion) * Previous metabolic/bariatric surgery * Current use of a stimulant medication * History of glaucoma * Current or recent (\<14 days) use of monoamine oxidase inhibitor * Known hypersensitivity to sympathomimetic amines * Any history of treatment with growth hormone * Any history of bulimia nervosa * Major psychiatric disorder as determined by the local medical monitor * Unstable and clinically-diagnosed (defined as documented in the medical record, if available) depression * Any history of active suicide attempt * History of suicidal ideation or self-harm within the previous 30 days of screening * Patient Health Questionnaire (PHQ-9) score \>15 at screening * Current pregnancy or plans to become pregnant during study participation * Current tobacco use * Alanine transaminase (ALT) or Aspartate transaminase (AST) \>/= 3 times the upper limit of normal * Bicarbonate \<18 mmol/L * Creatinine \> 1.2 mg/dL * Any history of seizures * Uncontrolled hypertension as determined by the local medical monitor * History of structural heart defect or clinically significant arrhythmia * Diagnosed monogenic obesity * Any history of cholelithiasis * Any history of nephrolithiasis * Clinically diagnosed hyperthyroidism * Untreated thyroid disorder * Any disorder, unwillingness, or inability, not covered by any other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol
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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.
Contacts and locations
Locations
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University of Minnesota
Minneapolis, Minnesota, 55455, United States
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