Promoting Healthy Children and Youth

NCT06977438 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: PEDS-2025-33936
• Study Type: interventional
• Target: 1,020
• Locations: 0 countries
• Sites: N/A

Brief Summary

The rapid emergence of new and highly effective obesity medications has turned the field of pediatric weight management on its head. Adolescents living with obesity, their caregivers, healthcare providers, healthcare systems, policymakers, and payors are now wondering what role health behavior and lifestyle treatment (HBLT) has in terms of body mass index (BMI) reduction, improvements in quality of life and cardiometabolic health, and mitigating nutritional concerns when medications are used. Is intensive (26+ hours) of HBLT needed or could low intensity HBLT be an equally effective alternative; and if so, for whom? Our proposed project will answer these important questions that arise daily in the clinical setting and will generate critical new insights to guide decision-making for teens with obesity and the stakeholders who care deeply about them.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

• Body Mass Index (BMI) Reduction

  Change in body mass index

  24 months

Study Arms (3)

High Dose HBLT

EXPERIMENTAL

Individuals in this group will be randomized in an open fashion to receive 26 hours of HBLT during the course of the study. Participants will have HBLT every two weeks during the study which will entail 45 minute virtual group classes with a 15 minute individual goal setting session.

Drug: Semaglutide

Medium Dose HBLT

EXPERIMENTAL

Individuals in this group will be randomized in an open fashion to receive 13 hours of HBLT during the course of the study. Participants will have HBLT every four weeks during the study which will entail 45 minute virtual group classes with a 15 minute individual goal setting session.

Drug: Semaglutide

Low Dose HBLT

EXPERIMENTAL

Individuals in this group will be randomized in an open fashion to receive 4 hours of HBLT during the course of the study. Participants will have HBLT at four timepoints during the study (Weeks 2, 18, 34 and 50) which will entail 45 minute virtual group classes with a 15 minute individual goal setting session.

Drug: Semaglutide

Interventions

Semaglutide DRUG

All participants in this study will receive treatment with Semaglutide

High Dose HBLT; Low Dose HBLT; Medium Dose HBLT

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 12 to \< 18 years at screening
• BMI \>/= 95th percentile based on age and sex

You may not qualify if:

• Diabetes (type 1 or 2) due to safety concerns about properly surveiling glycemic control virtually
• Current or recent (\< 6 months prior to screening) use of obesity medications
• Previous metabolic/bariatric surgery
• Current or recent (\< 6 months prior to screening) use of medication(s) to treat insulin resistance
• Hypertension
• Hypercholesterolemia
• History of treatment with growth hormone
• Eating disorder diagnosis
• Major psychiatric disorder
• Unstable clinically-diagnosed depression
• History of suicide attempt
• History of suicidal ideation or self-harm within 30 days of screening
• Current pregnancy or plans to become pregnant
• Tobacco use
• Uncontrolled hypertension

Sponsors & Collaborators

• University of Minnesota: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Novo Nordisk A/S: collaborator

MeSH Terms

Conditions

Pediatric Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 18, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 31, 2031
• Study Completion (Estimated): January 31, 2032
• Last Updated: February 10, 2026

Record last verified: 2026-02