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Can a pill and a coach beat teen obesity? massive new study aims to find out.

NCT ID NCT06977438

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether adding lifestyle coaching to a new weight-loss medication (GLP-1) helps teens with obesity lose more weight and feel better. About 1,020 teens aged 12-17 will take the medication and be assigned to either intensive or basic lifestyle support. The goal is to find the best way to combine medicine and healthy habits for lasting weight control.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,020 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2032

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 18 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: * Aged 12 to \< 18 years at screening * BMI \>/= 95th percentile based on age and sex at screening * Provide release of information for established primary health provider * Own a device capable of connecting to the virtual platform sessions with video Exclusion Criteria: * Diabetes (type 1 or 2) due to safety concerns about proper surveillance of glycemic control virtually * HbA1c \>/= 6.5% * Current or recent (\< 6 months prior to screening) use of FDA-approved obesity medications * Previous metabolic/bariatric surgery or metabolic/bariatric surgery planned during the study period * Hypertriglyceridemia (TG \>/= 500 mg/dL) * Any past or current diagnosis of an eating disorder (i.e. anorexia nervosa, atypical anorexia nervosa, bulimia nervosa) * Major psychiatric disorder (e.g. schizophrenia, bipolar disorder) * Unstable clinically-diagnosed depression, defined as requiring psychiatric hospitalization in the last six months) * History of suicide attempt * History of suicidal ideation or self-harm within 30 days of screening * Patient Health Questionnaire (PHQ-9) score \>/= 15 at screening * Current pregnancy, breast feeding, or plans to become pregnant * Females refusing to use effective contraception * Diagnosis of monogenic obesity due to mutations in POMC, PCSK1, or LEPR * Diagnosis of syndromic obesity including, but not limited to, Bardet Biedl or Prader-Willi Syndrome * History of cholelithiasis without cholecystectomy * History of pancreatitis * Personal history of first-degree relative history of medullary thyroid carcinoma and/or multiple endocrine neoplasia type 2 * Known hypersensitivity to GLP1 agonists * Other participants from the same household who are participating in this trial * Any disorder, unwillingness, or inability, which in the investigator's opinion might jeopardize the participant's safety or compliance with the protocol

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Minnesota, Center for Pediatric Obesity Medicine

    Minneapolis, Minnesota, 55414, United States

More trials for these conditions

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