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New combo approach tackles teen obesity: counseling plus pills

NCT ID NCT04873245

Disease control Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 1 time

Summary

This study tests whether combining lifestyle counseling with weight-loss medication helps teens aged 12–17 with severe obesity lose weight. About 120 participants will receive counseling and medication for a year. The goal is to find a practical, effective treatment that is easier to stick with than intensive programs alone.

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

120 people

The number who actually took part.

Started

Mar 2022

Finished

Jun 2026

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: * Obesity (Body Mass Index (BMI) \>/= 95th percentile or BMI \>/= 30 kg/m2) * Age 12 to \< 18 years old and Tanner stage \>1 Exclusion Criteria: * Diabetes (type 1 or 2) * Current or recent (\< 6 months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination phentermine/topiramate, liraglutide (or other GLP-1RA) and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion) * Previous bariatric surgery * Any history of treatment with growth hormone * Medically-documented history of bulimia nervosa * Any history of schizophrenia, psychosis, mania, chemical dependency * Unstable depression requiring hospitalization within the previous 6 month * Any history of suicide attempt * History of suicidal ideation or self-harm within the previous 30 days as determined at screening by a PHQ-9 score \>/= 15 or Suicidal ideation of type 4 or 5 on the C-SSRS * Current pregnancy or plans to become pregnant * ALT or AST \>/= 5 times the upper limit of normal * Creatinine \> 1.2 mg/dL * Uncontrolled hypertension as determined by the local medical monitor * Diagnosed and medically-documented monogenic obesity * Medically-documented history of cholelithiasis * Untreated thyroid disorder * Medically documented history of pancreatitis * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 * Clinically significant heart disease as determined by the local medical monitor * Personal history of malignant neoplasms within the past five years * Hypersensitivity to any component of semaglutide

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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.

Obesity, childhood

Contacts and locations

Locations

  • University of Minnesota, Delaware Clinical Research Unit

    Minneapolis, Minnesota, 55414, United States

More trials for these conditions

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