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

Short name GLOW

NCTNCT06977438Other idPEDS-2025-33936

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Not yet recruiting
Phase: Phase 4
Enrollment: 1,020 participants (estimated)
Sponsor: University of Minnesota · Other
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: 15 Oct 2026 (estimated)
Primary completion: 31 Jan 2031 (estimated)
Completion: 31 Jan 2032 (estimated)
First posted: 18 May 2025
Last update posted: 2 Oct 2026
Conditions: Obesity, Childhood

Timeline

1 trial · 1 not yet recruiting

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2026202820302032

Ph 4
GLOW
NCT06977438
est. 15 Oct 2026 to est. 31 Jan 2032

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

SemaglutideDrug

Arms3

Experimental
High Dose HBLT
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.
Experimental
Medium Dose HBLT
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.
Experimental
Low Dose HBLT
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Body Mass Index (BMI) Reduction
Time frame · 24 months
Registry description
Change in body mass index

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 12 Years up to 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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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