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Could a Weight-Loss pill help teens with type 2 diabetes?

NCT ID NCT04881799

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

  • University of Minnesota

    Minneapolis, Minnesota, 55414, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.