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Obesity, ChildhoodPhase 2QUESTNCT04873245

Lifestyle Counseling and Medication for Adolescent Weight Management

A Phase 2 study testing Intensive Behavioral Program and Semaglutide and Behavioral Program in people with Obesity, Childhood, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The prevalence of adolescent severe obesity is at an all-time high in the United States and the refractory nature of this disease has led to a serious and challenging conundrum in terms of how to provide effective, safe, scalable, and durable treatments without placing undue strain on the healthcare system. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Obesity, Childhood
What is being tested?
Intensive Behavioral Program and Semaglutide and Behavioral Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 siteUnited States
Study dates
15 Mar 2022to 30 Jun 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Obesity (Body Mass Index (BMI) >/= 95th percentile or BMI >/= 30 kg/m2)
  • Age 12 to < 18 years old and Tanner stage >1

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Minnesota, Delaware Clinical Research Unit

    Minneapolis, Minnesota, 55414

Other trials in United States

About this study

The prevalence of adolescent severe obesity is at an all-time high in the United States and the refractory nature of this disease has led to a serious and challenging conundrum in terms of how to provide effective, safe, scalable, and durable treatments without placing undue strain on the healthcare system. Clinical practice guidelines recommend behavioral interventions as the primary strategy for all ages and classes of obesity - moderate to severe. In 2017, the U.S. Preventive Services Task Force (USPSTF) released updated screening recommendations concluding that comprehensive, intensive behavioral interventions with a total of ≥26 contact hours over a period of 2-12 months resulted in weight loss in youth with obesity, with ≥52 contact hours leading to even greater weight loss and improvements in some cardiometabolic risk factors.

However, the practicality of delivering these types of intensive behavioral services to the millions of youth with severe obesity in the U.S. is debatable not only because of the treatment-resistant nature of severe obesity, but also due to the time-commitment, acceptability, and sustainability of this approach for adolescent patients and their families along with the extensive resources required to provide these interventions. Indeed, fewer than 50% of pediatric patients referred for weight management services enroll in treatment, and high attrition rates of up to 50% have been reported in behavioral-based clinical trials and in the clinical setting. Moreover, adherence to behavioral counseling significantly diminishes over time, which too often erodes early weight loss success and ultimately derails durability. The reality of what most patients/families are able to do and the unique physiological and psychosocial features of severe obesity in adolescence do not seem to align well with the degree of intensity of behavioral interventions shown to be effective by the USPSTF. Therefore, a critical appraisal of the feasibility, effectiveness, and sustainability of the USPSTF recommendations among adolescents with severe obesity is warranted.

While behavior change is an indispensable component of any effective weight loss approach, adjunctive strategies such as pharmacotherapy may enhance outcomes in adolescents with severe obesity. Many maladaptive behaviors attributed to obesity are driven by underlying biological forces, such as increased appetite and food palatability, that are largely beyond the control of the individual. Pharmacotherapy can help facilitate behavior change by disrupting core pathophysiological processes and restoring homeostasis to the energy regulatory system, therein enabling individuals to sustain healthy behavior change. Though under-explored as a treatment for adolescent obesity, pharmacotherapy along with relatively low-intensity behavioral counseling (<26 contact hours) represents a potentially effective, durable, and safe treatment strategy. This approach may be more practical and feasible to implement on a broad scale, be preferred by patients/families, utilize fewer healthcare resources, and cost less to deliver compared to comprehensive, intensive behavioral interventions.

Read the detailed description

This is a two-arm, randomized clinical trial in adolescents with severe obesity evaluating 52 weeks of intensive behavioral counseling, aligned with USPSTF recommendations (52 contact hours), vs. 52 weeks of medical management with semaglutide (glucagon-like peptide-1 receptor agonist) plus relatively low-intensity behavioral counseling (12 contact hours).

Being tested
Intensive Behavioral Program, Semaglutide and Behavioral Program
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive Behavioral ProgramBehavioural

    Participants randomized to this group will receive intensive behavioral therapy.

  • Semaglutide and Behavioral ProgramDrug

    Participants randomized to this group will receive semaglutide and behavioral therapy.

Study groups in NCT04873245
Study groupRoleWhat they receive
Intensive Behavioral Program ArmActive comparatorParticipants randomized to this arm of the study will receive intensive behavioral therapy. Participants will receive 52 weekly sessions (50% in person and 50% virtual).
Receives: Behavioral: Intensive Behavioral Program
Medication ArmActive comparatorParticipants randomized to this arm of the study will receive semaglutide and will receive behavioral therapy. Behavioral therapy will consist of 12 monthly sessions (50% in person and 50% virtual).
Receives: Drug: Semaglutide and Behavioral Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change in Body Mass Index

    The percent change in body mass index (BMI) from Baseline to Week 56 will be calculated. BMI is defined as a person's weight in kilograms divided by the square of height in meters.

    Measured: Randomization to Week 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2021
  2. Study start15 Mar 2022
  3. Primary completion29 Jun 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants who qualify will be randomized to receive either intensive behavioral therapy or treatment with semaglutide plus a less intensive behavioral therapy program.
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04873245
Sponsor's protocol ID
PEDS-2021-29784
Acronym
QUEST
Status last verified
Nov 2026
First submitted
30 Apr 2021
Last updated
6 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: To be determined

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intensive Behavioral Program and Semaglutide and Behavioral Program in people with Obesity, Childhood, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Body Mass Index (time frame: Randomization to Week 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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