Could a Weight-Loss pill help teens with type 2 diabetes?
NCT ID NCT04881799
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests the drug phentermine/topiramate (Qsymia) in 13 adolescents aged 12-20 who have both obesity and type 2 diabetes. The drug is already approved for weight loss in adults. The study aims to see if it can safely lower body mass index (BMI) and improve blood sugar control over six months. Participants receive either the drug or a placebo pill.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Phentermine/Topiramate (Qsymia)
- What this could lead to
- If it works, this could offer a new treatment option for teens with type 2 diabetes and obesity, helping them lose weight and better manage their diabetes.
- What could go wrong
- This is a very early, small trial with only 13 participants, so results may not apply widely. The drug can cause side effects like dizziness, dry mouth, and tingling.
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
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
13 people
The number who actually took part.
- Started
-
Jul 2022
- Expected to finish
-
Oct 2026
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
-
12 to 20 years
- Sex
-
Anyone
- Healthy volunteers
-
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: * Ages 12 to \</= 20 years at study entry * Obesity (BMI \>/= the 95th percentile for age and sex) * HgbA1c \>/= 6.5% at type 2 diabetes diagnosis * Negative diabetes auto-antibodies * English-speaking and Spanish speaking * For participants of child-bearing potential: when sexually active, agreement to use two forms of highly effective contraception (oral contraceptive pill, IUD, implant, and/or condoms) during study participation Exclusion Criteria: * Pregnancy or lactation * Newly-initiated or change in dose of weight altering medication within past 6 months, including SGLT-2 inhibitors and DPP-IV inhibitors, liraglutide 1.8 mg and exenatide ER. * Current or recent (\< six months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination PHN/TPM, semaglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion) * Current use of sulfonylureas * Previous metabolic/bariatric surgery * Current use of a stimulant medication * History of glaucoma * Current or recent (\< 14 days) use of monoamine oxidase inhibitor or carbonic anhydrase inhibitors * 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 or PHQ-9 score of \>/= 15 * Any history of active suicide attempt, a "yes" answer to Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) on the "Suicidal Ideation" portion of the C-SSR, or a "yes" to answer to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS * History of suicidal ideation or self-harm within the previous 30 days or a "yes" answer to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act, or behavior) on the "Suicidal Behavior" portion of the C-SSRS and the ideation or behavior occurred within the past month. * Current pregnancy or plans to become pregnant during study participation * Current tobacco use * ALT or AST \>/= 3 times the upper limit of normal * Moderate (Child-Pugh score 7-9) or severe (Child-Pugh score 10-15) * Bicarbonate \<18 mmol/L * Moderate (creatinine clearance \[CrCl\] greater than or equal to 30 and less than 50 mL/min) or severe (CrCl less than 30 mL/min) renal impairment * Any history of seizures • BP for ages 13 and older of \> 130/80 on 3 separate measurements and for age 12 \> 95th percentile on 3 separate measurements * HR ≥120 bpm on 3 separate measurements * 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 or TSH below the lower laboratory limit of normal * Any disorder, unwillingness, or inability, not covered by any other exclusion criteria, which in the investigator's opinion may put the participant at risk
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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, 55414, United States
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