Testing semaglutide with lifestyle support in teens with childhood obesity
Tests semaglutide with lifestyle support in teenagers, ages 12 to 18, with obesity.
Plain-language title generated from the registry record
Registry title: GLP-1 Plus Lifestyle for Overall Wellness: Find Your Way Forward
Key facts
- Where
- Minneapolis, United StatesSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 18 years old?
Source: NCT06977438, who can take part
Where in United States
- University of Minnesota, Center for Pediatric Obesity MedicineMinneapolis, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Minnesota
- Trial code
- NCT06977438
- Record updated
- 20 October 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: 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; Diabetes (type 1 or 2) due to safety concerns about proper surveillance of glycemic control virtually; 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; 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; Any disorder, unwillingness, or inability, which in the investigator's opinion might jeopardize the participant's safety or compliance with the protocol; HbA1c >/= 6.5%; Hypertriglyceridemia (TG >/= 500 mg/dL); 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; Other participants from the same household who are participating in this trial.