When to add Weight-Loss pills? new study tests timing for teens
NCT ID NCT04007393
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 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: * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Adolescent obesity are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
- A protein supplement may fight fatty liver in teens
- Can we predict kidney damage in young diabetics before it starts?
- Hoops for health: can basketball teach teens to beat obesity and boost mood?
- Sleep coaching may be the missing ingredient in teen weight loss
- Can day treatment beat full hospital stays for obese teens?
- New program aims to help teens with type 1 diabetes manage weight safely