Obesity, ChildhoodPhase 4GLOWNCT06977438
GLP-1 Plus Lifestyle for Overall Wellness: Find Your Way Forward
A Phase 4 study testing Semaglutide in people with Obesity, Childhood, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Semaglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,020 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2026to 31 Jan 2032
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Minnesota, Center for Pediatric Obesity Medicine
Minneapolis, Minnesota, 55414
Cameron Naughton, 612-625-3623, naug0009@umn.edu
Aaron S Kelly, PhD
About this study
Official title: GLOW (GLP-1 Plus Lifestyle for Overall Wellness)
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.
Read the detailed description
The premise underpinning our proposed project stems from the conceptual framework that obesity medications beneficially alter the underlying pathophysiology that largely drives eating behaviors (appetite, satiety, cravings, and "food noise"), thereby lessening the need for high doses of HBLT. In this way, medications can unburden adolescents living with obesity, their caregivers, healthcare providers, health systems, and payors from the need to engage in and provide intensive HBLT. This framework has directly informed our research strategy and methodological approach, including the design of our trial and the variables we have chosen to assess. Indeed, we plan to compare three different doses of HBLT in terms of their ability to improve health-related outcomes while having a keen eye on nutritional safety and eating disorders. The design and patient-centered outcomes for our trial have been carefully and thoughtfully crafted to provide evidence-based clarity on critical decisional dilemmas regarding how much HBLT is needed to get the most out of obesity pharmacotherapy and how social determinants of health (SDOH) factors can help guide treatment strategies to maximize effectiveness and safety.
- Conditions
- Obesity, Childhood
- Being tested
- Semaglutide
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
All participants in this study will receive treatment with Semaglutide
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI) Reduction
Change in body mass index
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start15 Nov 2026 (estimated)
- Primary completion31 Jan 2031 (estimated)
- Study completion31 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Aaron Kelly, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977438
- Sponsor's protocol ID
- PEDS-2025-33936
- Acronym
- GLOW
- Status last verified
- Oct 2026
- First submitted
- 9 May 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be available through the Patient Centered Outcomes Data Repository (PCODR)
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLOW (GLP-1 Plus Lifestyle for Overall Wellness)
- ClinicalTrials.gov ID
- NCT06977438
- Acronym / sponsor ID
- GLOW / PEDS-2025-33936
- Conditions
- Obesity, Childhood
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Novo Nordisk A/S
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 31 Jan 2031 (estimated)
- Study completion
- 31 Jan 2032 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The premise underpinning our proposed project stems from the conceptual framework that obesity medications beneficially alter the underlying pathophysiology that largely drives eating behaviors (appetite, satiety, cravings, and "food noise"), thereby lessening the need for high doses of HBLT. In this way, medications can unburden adolescents living with obesity, their caregivers, healthcare providers, health systems, and payors from the need to engage in and provide intensive HBLT. This framework has directly informed our research strategy and methodological approach, including the design of our trial and the variables we have chosen to assess. Indeed, we plan to compare three different doses of HBLT in terms of their ability to improve health-related outcomes while having a keen eye on nutritional safety and eating disorders. The design and patient-centered outcomes for our trial have been carefully and thoughtfully crafted to provide evidence-based clarity on critical decisional dilemmas regarding how much HBLT is needed to get the most out of obesity pharmacotherapy and how social determinants of health (SDOH) factors can help guide treatment strategies to maximize effectiveness and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose HBLT | Experimental | Drug: SemaglutideIndividuals 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. |
| Medium Dose HBLT | Experimental | Drug: SemaglutideIndividuals 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. |
| Low Dose HBLT | Experimental | Drug: SemaglutideIndividuals 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAll participants in this study will receive treatment with Semaglutide | Drug | High Dose HBLT, Low Dose HBLT, Medium Dose HBLT |
Primary outcome
Body Mass Index (BMI) Reduction
Time frame: 24 months
Change in body mass index
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Yes. Results will be available through the Patient Centered Outcomes Data Repository (PCODR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron Kelly, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide 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 4 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: opening soon, as of the sponsor's last update on 20 Oct 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dawn Nederhoff (612-626-2349, epper019@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) Reduction (time frame: 24 months). 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 20 Oct 2026.