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When to add Weight-Loss pills? new study tests timing for teens

NCT ID NCT04007393

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at 150 teens aged 12-17 with severe obesity to find the best time to add a weight-loss pill (phentermine) if lifestyle changes alone weren't enough. Participants first tried lifestyle therapy for 12 or 24 weeks, then those who didn't lose enough weight started the medication. The goal was to see how much their body mass index (BMI) changed over 48 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Phentermine
What this could lead to
If successful, this could show doctors the best way to combine lifestyle changes with medication to help teens with severe obesity lose weight more effectively.
What could go wrong
This is a small, early-phase study (Phase 2) with only 150 teens. The results may not apply to all teens, and phentermine can have side effects like increased heart rate or insomnia.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

150 people

The number who actually took part.

Started

Nov 2019

Finished

Mar 2025

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 17 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: * Provision of signed and dated informed assent form; * Provision of signed and dated informed parental consent form from at least 1 legal parent/guardian; * Stated willingness to comply with all study procedures and availability for the duration of the study; * BMI \>/= 1.2 times the 95th percentile or BMI \>/= 35 Kg/m2, whichever is lower; * Tanner stage \>/= 2; * Male or female, aged 12-17 at time of consenting; * For females of reproductive potential: when sexually active, agreement to use highly effective contraception (oral contraceptive pill, intra-uterine device (IUD), or implant) during study participation; * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. Exclusion Criteria: * Contraindications to phentermine or topiramate use according to package inserts, including: history of glaucoma; current or recent (\< 14 days) use of monoamine oxidase inhibitor; known hypersensitivity to sympathomimetic amines; current pregnancy, plans to become pregnant, or if sexually active refusal to use 2 forms of birth control; history of cardiac disease including coronary artery disease; clinically significant cardiac arrhythmias; heart failure or uncontrolled hypertension; * Diabetes (type 1 or 2); * Presence of cardiac pacemaker; * Current or recent (\<6 months prior to enrollment) use of weight loss medication(s); * Current use of weight-altering medication(s) (e.g., atypical antipsychotic, metformin) unless dose has been stable for past 6 months; * Current use of other sympathomimetic amine such as attention-deficit hyperactivity disorder (ADHD) stimulants; * Seizure disorder (other than infantile febrile seizure); * Previous bariatric surgery; * Recent initiation of change in dose (\< 3 months prior to enrollment) of anti-hypertensive or lipid medication(s); * Tobacco use * History of or current diagnosis of schizophrenia, psychosis, mania, chemical dependency; * Unstable depression or anxiety that has required hospitalization in the past year; * Any history of suicide attempt; * Suicidal ideation or self-harm within 12 months prior to enrollment; * Bicarbonate \< 18 mmol/L; * Creatinine \> 1.2 mg/dL; * History of cholelithiasis; * History of nephrolithiasis; * Untreated thyroid disorder; * Hyperthyroidism; * Breastfeeding

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Conditions

The condition(s) this trial relates to.

obesity disorder Pediatric Obesity

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.