GLP-1 Plus Lifestyle for Overall Wellness: Find Your Way Forward

NCT06977438 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: PEDS-2025-33936
• Study Type: interventional
• Target: 1,020
• Locations: 1 country
• Sites: 1

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 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 to receive high dose HBLT during the first 52 weeks of the study. The HBLT will consist of group classes with detailed education, skill building and strategies on specific topics in addition to individual goal setting sessions.

Drug: Semaglutide

Medium Dose HBLT

EXPERIMENTAL

Individuals in this group will be randomized to receive medium dose HBLT during the first 52 weeks of the study. The HBLT will consist of group classes with condensed information, skill building and strategies in addition to individual goal setting sessions.

Drug: Semaglutide

Low Dose HBLT

EXPERIMENTAL

Individuals in this group will be randomized to receive low dose HBLT during the first 52 weeks of the study. The HBLT will consist of group classes with a brief overview of topics in addition to individual goal setting sessions.

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 at screening
• Provide release of information for established primary health provider
• Own a device capable of connecting to the virtual platform sessions with video

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Minnesota, Center for Pediatric Obesity Medicine

Minneapolis, Minnesota, 55414, United States

Location

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 Officials

• Aaron Kelly, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawn Nederhoff

CONTACT

612-626-2349; epper019@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The investigator, participant and the study coordinator will be blinded to the HBLT treatment. Only the dietitians and study monitor will know the HBLT treatment assignments of the participants.
• 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): October 1, 2026
• Primary Completion (Estimated): January 31, 2031
• Study Completion (Estimated): January 31, 2032
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be shared after the Patient Centered Outcomes Research Institute (PCORI) accepts the Final Research Report following peer review. As set forth in PCORI's Data Sharing Policy, study data will be available for third-party requests when one of two conditions is met (whichever is met first): * PCORI makes the Final Research Report available on the PCORI website * At the time of publication of the research project's primary results in a peer-reviewed journal.

Locations

US (1)